Mark Butler (Hindmarsh, Australian Labor Party, Deputy Manager of Opposition Business in the House of Representatives) Share this | Link to this | Hansard source

It's a great pleasure to rise on behalf of the opposition to address this bill, the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 and to speak on behalf of the opposition on health matters for the first time. It's a particular pleasure to deal with a bill that covers the operations of the Therapeutic Goods Administration, one of the great agencies of government in this country which has an extraordinary reputation and an extraordinary track record. As the Parliamentary Secretary for Health under the first Rudd government, I had the great privilege of having ministerial responsibility for the TGA, so it's a great pleasure to be associated with their work again.

This is a bill that the opposition will be supporting without substantive amendment in either house, although I will be moving a second reading amendment. We particularly recognise the urgency of one element of this bill, because it goes to the smooth and lawful operation of the vaccine rollout. So we recognise the urgency of the passage of this bill through the House and the Senate. It's passing in a timely fashion means that Australians can have confidence that the vaccine rollout will operate in an expeditious manner, and in an effective manner as well.

There are a number of measures contained in this bill that are unrelated to the vaccine rollout, and I'll address them. Although there are some comments that I and some other members of the opposition may have in relation to those measures, we will, as I said, be supporting the bill without amendment.

The most pressing matter in the bill is the vaccine labels, or the labels that will be affixed to the bottles of the different vaccines that will be part of the COVID-19 vaccine rollout. It is important to say, as I think all members of this House understand, that it is going to be a monumental challenge to roll this vaccine out successfully for the country. It is not particularly an Australian challenge; it is a challenge that countries around the world are facing. We are starting to understand the enormity of the logistical challenge involved in undertaking as many as 50 million to 60 million vaccinations over the coming six, seven or eight months, depending on how quickly we're able to do it. Not only are two doses of the different COVID-19 vaccines required, but Australia is also going to have to undertake its usual round of flu vaccinations as we head into the flu season in winter, and there needs to be proper space in between dose one and dose two of the COVID-19 vaccine but also in between the COVID-19 vaccinations and the flu vaccination. The enormity of this is something that the minister has said and experts have said—I think we all understand—is of a scale that we've never quite dealt with before. It is hard, really, to overstate the scale of what we're embarking upon.

I've said over the last couple of days, as I start the job of shadow minister for health and ageing, that there remain a number of logistical questions that need clearer answers from the government. They are important questions not only for the community to have confidence that this vaccine rollout is going to operate in a smooth, timely and effective fashion but also for practitioners and aged care facilities, for the GP practices that have stuck up their hand to be part of this and for the state governments that will have responsibility for some elements of the rollout, not the least of which being the storage of the Pfizer vaccine, which requires very cold storage at about minus 70 degrees centigrade. There remain unanswered very important questions that go to the logistical challenge. I will talk about a couple of them tonight because it is important and, in spite of the fact that we are bringing what is objectively a very constructive approach to this question, it is our job to continue to ask the questions that the community—the medical community and the broader community—are themselves asking.

The first question obviously is: when are we going to get supplies of the vaccines? We understand that there are issues beyond the control of any particular government that is seeking to import vaccines from overseas manufacturing countries. There is obviously a very live debate underway within Europe about where the vaccines manufactured in Europe are going, given the enormous challenge that most European countries are facing now. We're blessed with not having here the scale of the challenge of the ferocity of the virus in Europe, the US, Brazil and many other countries beside, but we need to understand when Pfizer vaccines are going to land in Australia. There will have to be batch testing undertaken by the Therapeutic Goods Administration. That will take maybe up to two weeks, and only then will we be able to see those vaccine supplies rolled out to the 30 or 50 Pfizer hubs that will be in place around the country and from there rolled out to vaccination points of presence. We need to understand when those are going to land.

We are already into February. The Prime Minister committed to four million vaccinations being completed by the end of March. There is some suggestion that that commitment is going to seep into April, but, given that we're not in February, it would appear we're still some weeks away from the vaccines' being ready to be put into people's arms, given that we've got at least a couple of weeks of batch testing. These things are starting to slip. If the front end of the vaccine rollout slips too much, it will be very difficult, given the flu vaccination campaign we're also going to have to undertake in winter, to meet the hard commitment that the Prime Minister and the Minister for Health have given to have the country vaccinated by the end of October. These are important considerations, first and foremost, obviously, for the community as it thinks about how we're going to come through this health challenge, but they also go to economic confidence, to business confidence, in being able to plan and to have some light at the end of this tunnel.

In addition to the question of suppliers, it's not just Pfizer; it's also the AstraZeneca suppliers who will be working to have more than three million doses brought in from overseas. That appears to have been reduced by a little bit more than half. We might have 1.4 million doses, or thereabouts, from AstraZeneca. Again, there are challenges with the speed with which the virus that is the viral vector for that vaccine is being manufactured around the world. We understand that is not a matter within the control of the government, but we need some clarity around the arrival dates—the landing dates of those vaccines—so we can get them out into the system and get injections into arms.

People do remember that the Prime Minister said that we were first in the queue. We understand there are emergencies at a level—in the Northern Hemisphere particularly—that, luckily, we don't confront here, but tens of millions of people around the world have already been vaccinated. Millions are being vaccinated every day. Countries like Israel have already vaccinated more than one-third of their populations. Millions are being vaccinated in the US, the UK and Europe, and not a single injection has gone into an Australian arm. Australians, at some point, need some clarity around these questions.

I've also asked questions about the online booking system that the government has announced it is preparing. This is utterly critical to the smooth rollout. If the only way members of the community not in a residential aged-care facility are going to be able to book and access a vaccination is through a single online entry point that's still in construction, we need to know when that will be ready. We need to have confidence that, frankly, the performance of this online tool will be better than some of the other online or IT applications this government has had responsibility for. The COVIDSafe app has been pretty much a failure. The online census was pretty much a failure. There are other instances as well. The community needs confidence. GP practices and other parts of the medical community that are going to roll this thing out still don't know how the booking system will work. If you are a member of the community, a patient wanting to have one of these vaccinations, all you know at the moment is that you're going to have to access an online booking system, you'll be connected to a GP practice, and there's every chance it won't be your own GP practice, because not every GP practice is going to be undertaking these things. What will that mean for patients that have a particular relationship with their GP? What will it mean for the discussions that some patients will need to have with their general practitioner about being confident that the vaccination is the right thing for them? And so on and so forth. We need answers to these questions.

A little bit down the track, we also need some answers to the questions around the negotiations that are taking place with other vaccine suppliers. We know, for example, that the other highly effective, highly efficacious mRNA vaccine, which is produced by Moderna, is not something the Australian government has a deal on. We have no deal with Moderna. We have a deal with Pfizer for 10 million doses to vaccinate five million people. The other mRNA vaccine with highly effective rates is not something Australians are going to have access to, at least at the moment. We don't have a deal. What is the government doing to access that down the track? We know from medical experts that, as we start to think about boosters and as we start to think about vaccines being modified to take account of new variants that we're already seeing around the world, mRNA vaccines, which are a new technology, are going to be very important and are very effective, apparently, at adapting to those new variants and can be adapted to provide boosters as well. Australia needs to get in on that. We need to know what the government is doing to get into the market of the Moderna vaccine—J&J and others in the market as well. We say that in good faith. We want to be as constructive as possible, but these are things that members of the community want the government to start answering.

It's also important that we look to some of the polling that was released today by Newspoll which reminds us that there is still substantial vaccine hesitancy in the community. Our country can be very proud of its track record on immunisation. There is a very strong track record of bipartisan support between governments of different persuasions for educating the community about the broader benefits—not just the individual benefits but the herd immunity benefits—of strong vaccination rates. I know that in only the past couple of weeks the minister released some data showing that we've got to fantastic levels of childhood immunisation. The level is 95 per cent or thereabouts generally for five-year-olds and even greater, 97 or 98 per cent, for Indigenous five-year-olds. These are figures of which all Australians can be rightly proud. Governments of both political persuasions over many years have got us to that point. It is important we work on that track record, use that track record, as a foundation to make sure as many Australians as possible are vaccinated against COVID-19.

Newspoll says 25 per cent of the community still don't intend to take up a vaccine. Let's leave aside the fact that if 75 per cent want to get one, or probably want to get one, there's still the logistical challenge of connecting them to a needle. That 25 per cent is a worrying figure. The Newspoll shows, as I think all members of this House would understand from talking to their own communities, that there are particular cohorts of the population who have higher levels of hesitancy. Women between 25 and 34 and between 35 and 44 years of age are one example, but there are others as well. It is important that as a parliament we continue to nurture understanding of the broader, and the individual, benefits of everyone getting this vaccine unless there's some extraordinary circumstance as to why they shouldn't.

That's why we've supported the information campaign that the government is running. At the moment, it's running on TV and elsewhere as well. This is a campaign that we've supported. We've supported this type of education campaign in the past. We think this is the right thing to do. But I have to say that's why, in the face of all of that—the challenge of getting this thing out, the challenge we have of ongoing vaccine hesitancy in the community—it is so irresponsible for the Prime Minister to continue to refuse to condemn the grossly irresponsible fearmongering undertaken in particular by the member for Hughes, generally around our COVID-19 response and, most recently, in relation to the vaccine program.

The Prime Minister was asked at the Press Club yesterday whether he would, as the AMA and the College of GPs have done over the last 24 hours and as vaccine and immunology expert after expert has done over the last several weeks, condemn the inflammatory, irresponsible remarks of the member for Hughes—things like effectively accusing the Chief Medical Officer of crimes against humanity, or suggesting that advocates of mask wearing are involved in child abuse. They are extraordinarily inflammatory remarks undertaken through his vast social media platform that, as I said today, reaches more people, unfortunately, than the Department of Health's Facebook page does. When the Prime Minister was asked to echo those condemnations from the AMA and other health bodies, he said instead that the member for Hughes is doing a good job. He said instead that the member for Hughes wasn't his doctor. It was reminiscent of his remark during last year's bushfire emergency that he 'doesn't hold a hose, mate'. It is time for the Prime Minister to step up and take responsibility and recognise the damage the member for Hughes is doing to the national vaccination campaign.

The Prime Minister talked a lot last year about 'team Australia'. He talked a lot about the importance of all hands being on deck to get through this pandemic emergency. And he was absolutely right. We as an opposition were as constructive as we possibly could be in supporting every measure the government put in place to respond to this pandemic, whether it was a health measure or whether it was an economic measure. We suggested improvements from time to time, almost all of which were taken up by the government. That was our job. That's what the community wanted us to do, because the community wanted their governments to succeed. They didn't really care whether the government was Liberal or Labor, at a federal level or at a state level; everyone just wanted their governments to succeed and they wanted their oppositions to be as constructive as possible. And that is what we did. That's what the Prime Minister asked us to do and it's what we did in response. But what is sauce for the goose is sauce for the gander. If that's the approach the Prime Minister is asking the entire community to undertake, he's got to call out the member for Hughes and force him into line as well.

I now turn to the specific measures within the bill. As I said, we intend to support this bill. The Therapeutic Goods Act currently requires all medicines and vaccines to display on their label the listing number they have as part of their registration on the Australian Register of Therapeutic Goods, the ARTG. That's for good reason—so that consumers and providers know that medicines and vaccines, therapeutic goods, that are circulating through the community have been through the proper process and can be traced to the ARTG. The challenge for the vaccine campaign is particularly for vaccines manufactured overseas in manufacturing operations that are ramping up very quickly to supply vaccines to a whole range of different countries, as customers aren't able to comply with those labelling requirements. And we need those vaccines as quickly as possible, as I've tried to outline in my earlier remarks.

The other challenge, particularly with the Pfizer vaccine, as I think members of this House now understand, is that it needs to be stored at minus 70 degrees, so it simply can't have labels; labels can't be put on bottles that are stored at that temperature. This bill seeks to exempt those vaccines from the existing legislative requirement to have their listing number on the label. In some cases, there won't be a label, particularly on the Pfizer vaccine. Instead, the departmental secretary will be able to ensure that those listing number arrangements are published online on the Department of Health website, and in other ways as well. This is obviously important to ensure that we can get this thing into people's arms as quickly as possible. For that reason, the opposition supports the bill.

There are matters in this bill that are unrelated to the vaccine rollout. That's convenient. I guess these are things that have been waiting to come through the parliament for some time. Although they're not necessarily matters that have the same level of urgency as the vaccine arrangements, they are things that we nonetheless support. The first is the question of pharmacist substitution. Members of this House will have heard story after story, for some years before COVID, of medicine shortage in Australia. A number of members of the medical and consumer community—and some members of this side of the House may make remarks about this—have said for some time that Australia needs to diversify its supply arrangements to deal with this sort of regular problem we have of medicines being in short supply. Under the existing legislative regime, pharmacists are able to substitute a different brand of the same medicine when the brand that has been prescribed by the prescribing doctor is not available or is in short supply. This bill will allow pharmacists to supply not only a different brand of the same medicine or the same therapy but a different therapy altogether. They won't have carte blanche to do this under this legislation. The secretary of the department will have the ability to prescribe a particular type of medicine that can be substituted—it's not carte blanche; it will be a particular type—and pharmacists will be able to do that. This is important when a patient needs a particular therapy and that brand's not available, and a different brand of the same therapy is not available, and the prescribing doctor is not available to issue a new prescription. So there are circumstances where this is important for quality of care.

There are some concerns circulating through parts of the medical community that these safeguards aren't entirely adequate, that there should be some further safeguards than those that I've just outlined. We've encouraged them to make those concerns known to the government. If the government is minded to make some changes that might improve those safeguards, then obviously we would look at that very favourably. But I will say that, in their current form, we think these provisions are worthy of support, and we will be supporting them.

The other element of the bill that I want to address is the medical devices register. I'm very glad to see that this is contained in this bill. This has been a longstanding complaint. For a long time there have been calls to improve the traceability of medical devices. We all know that when adverse events or other safety concerns arise about a particular medical device, or a therapy for that matter, it is important to be able to trace who has used that therapy or had that medical device implanted. Currently we can't do that. There have been a range of issues or scandals—call them what you will—around devices like transvaginal mesh and textured breast implants where it can be difficult to trace patients or members of the community who have had those devices implanted so that those adverse events can be dealt with. There have long been calls for this reform. A Senate inquiry that was initiated by members of the Labor Party over recent years made that call. Many other groups in the community have as well.

The government has decided to adopt a unique device identifier system that would ensure that every device has a UDI or identifier. That would enable patients to be traced if they need to be because some issue has arisen with that particular device. This is a system that the EU, the United States and Japan have already rolled out, or are in the process of rolling out, and we think it's something we should lend our support to. Again, I offer the opposition's support to that element of the bill. I note that this legislation doesn't actually create the scheme; it creates a regulation-making power for the department to set up this UDI scheme by regulation. It goes without saying that Labor would examine any regulations that ultimately might be made by the secretary and the minister very closely.

There are a couple of other additional amendments I'll quickly address. Most of them are technical in nature, so I won't go through them. There is, though, an important measure to protect from criminal responsibility officers of the TGA undertaking work that we want them to do. Members of parliament will understand from the dealings they have with their own community the proliferation of online and other means of access that have just cropped up. People are buying therapies online from overseas, getting them mailed. There are other ways in which you can access therapies that aren't on the ARTG, that are not on the Register of Therapeutic Goods, that have not gone through a proper TGA approval and assessment process. There is a whole range of reasons why this is happening, but it is important that we be alive to that and agile enough to deal with the issues that that throws up.

One of those issues is that we want the TGA to test these things. If these things are circulating in our community, whether bought locally or bought overseas online, we want the TGA to use its extraordinary expertise, through its laboratories and such, to be able to test these so-called therapies. A part of the problem, though, is that it's against the law to possess them. We don't want our TGA lab officers and other officers to be subject to criminal charges because they are possessing something that is unlawful to possess. So we support the proposal the government has included in this bill to provide a shield to TGA officers—obviously only in authorised circumstances; it's not a carte blanche for them—to possess these therapies in order for them to undertake their important work.

Labor support this provision. We support the bill more broadly. There are some other issues that I've tried to address that members of the community have raised with us about different aspects of the bill. We particularly support the urgent measure that deals with some of the particular logistical challenges of the vaccines that are being imported for supply here in Australia that wouldn't comply with the existing legislation, and we commend the government for bringing that forward.

There are, though, concerns that we do have that I tried to outline in my remarks about whether this parliament is united in its support for the public health advice that members of our public health community have been working so hard to prepare day in, day out through this pandemic and the reluctance, the refusal of the Prime Minister to bring his own team in a united fashion to that community effort. In that vein, I move the following amendment:

That all words after 'that' be omitted with a view to substituting the following words:

'whilst not declining to give the Bill a second reading, the House condemns the ongoing campaign by some government members against the independent and expert Therapeutic Goods Administration, and urges the Prime Minister to finally censure those members.'

Ross Vasta (Bonner, Liberal Party) Share this | Link to this | Hansard source

Is the amendment seconded?

Shayne Neumann (Blair, Australian Labor Party, Shadow Minister for Veterans' Affairs and Defence Personnel) Share this | Link to this | Hansard source

I second the amendment and reserve my right to speak.

Ross Vasta (Bonner, Liberal Party) Share this | Link to this | Hansard source

The honourable member for Hindmarsh has moved as an amendment that all words after 'that' be omitted with a view to substituting other words. If it suits the House, I will state the question in the form that the words proposed to be omitted stand part of the question.

David Gillespie (Lyne, National Party) Share this | Link to this | Hansard source

The Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020 involves some rather technical changes to the operations of the Therapeutic Goods Act. The TGA, the Therapeutic Goods Authority, is a world renowned regulator which analyses drugs, vaccines, medical devices, implants, prostheses et cetera that are then defined as therapeutic goods. The amendments support existing processes that ensure Australians continue to get the medical devices, drugs and vaccines that we have been used to, particularly in the post-COVID world. I'll outline some of those changes in subsequent comments. As you can appreciate, Mr Deputy Speaker, with the COVID crisis there were interruptions to supply chains around the world—not only in Australia but really worldwide. Some of these changes have been brought to fruition as a result of that, but they are basically very safe, commonsense responses to a problem that emerged.

There are also regulations to enable a system to be set up so that there's a universal device indicator, so that we can create a register of the ever-increasing numbers of medical devices, prostheses, implants or medical gadgets that remain inside humans, like pacemakers, hip replacements, knee replacements or meshes—things like that—so that we become in tune with what other regulators around the world are doing, including in the EU and the US. That is a really great initiative. Some prostheses and medical devices already have registers and, in the orthopaedic world, have had them for some years. But this will, over a period of four years, allow for digital recording, such as in My Health Record, and allow for surveillance of side effects, for recalls, for health statistics on outcomes et cetera. It's an initiative which I think will add another layer of safety in that sort of device use in humans. There is a history of problems with devices that only become apparent after a certain time, like some of the side effects of breast implants or the pelvic mesh, which was hailed as a breakthrough, only to find out that it caused problems later on.

But the main change is allowing, in a regulatory and legislative sense, the application of common sense if there is a critical shortage of medicines. Currently in the system, if there is a shortage and there is a Serious Shortages Substitution Notice issued by the TGA, then, state-by-state, each state can allow the pharmacist to dose-substitute. This bill will allow the pharmacist to make authorised delivery of an equivalent generic or equivalent dose or formulation—so, rather than a capsule, a tablet, say. Or, instead of a 20-milligram tablet, give them two 10-milligram tablets. Or if there was a patch that delivered a medicine absorbed through the skin and that wasn't available, a cream could be used. So a lot of this is just putting legislative clarity and power behind what are sensible, professional decisions. If there's a shortage of a particular original brand, it can be replaced with a generic, or an equivalent molecule made by a different maker.

It will also, as the previous speaker mentioned, offer some protections for officers of the Therapeutic Goods Administration who are analysing drugs which were hitherto illegal. We're all familiar with the black market of illegal muscle-enhancing drugs, or drugs that are used to improve sporting performance. For us to know what's going on with these drugs in humans, at some stage the TGA will have to analyse them, but we don't want our chemists and biochemists being nabbed because they are in possession of illegal goods.

Another issue is creating what's called data protection. Everyone's familiar with patents for drugs. Data protection is for all the information that's behind getting a drug or a device evaluated and proved to be safe and effective. It's all the data that goes with it. It's allied to part of the patent but it's a separate process. People who've spent billions of dollars and many years getting all this information together to get it licensed have some legal rights to have their data protected so that some subsequent manufacturer can't just come along and get its equivalent drug licence on the basis of that data. So this will clarify data protection. It is for a limited number of years, but it means the secretary will know—it'll be recorded—that that data is protected to the use of that drug or that owner of that information.

It also clarifies in a legislative sense the declaration of a good as not being a therapeutic good. A lot of claims are made about substances that are sold for people's health. It's a bit of a vague area, and this declaration will mean that people won't be able to make outrageous claims about a so-called therapeutic effect of a drug or a device if it doesn't have it. To me, this seems like a really sensible idea, because there are some lotions and potions that people think are a registered therapeutic good and are definitely going to have an effect. If it has been analysed by an internationally renowned organisation, like Australia's TGA, and it has been proven not to have any therapeutic outcome, people can still buy it but the makers can't use and advertise that.

This bill is very technical. There are a lot of things that maybe only boffins or pharmacists or pharmaceutical companies will appreciate the benefit of, but it's all sensible stuff. It all keeps our system up to date. If there are disruptions to the supply chain again and there are shortages, pharmacists, who have a lot of university training and learning behind them, will be able to substitute appropriate medications without having to go through a rigorous process or contact the original prescribing doctor.

It also incorporates pretty much commonsense legislative changes to include the poison standard in other sections from time to time. Obviously the poisons schedule changes, and it will facilitate appropriate use of that information elsewhere.

Our TGA has been very busy analysing all the vaccines that are coming through the works. It is a national asset. Our pharmaceutical system really is a highly regarded system internationally, both the TGA and our allied processes for putting things on the Pharmaceutical Benefits Scheme. I support this bill, which has a lot of commonsense and safe procedures in it, and I commend it to the House.

Peta Murphy (Dunkley, Australian Labor Party) Share this | Link to this | Hansard source

The COVID pandemic has seen medical workers, including doctors and nurses, working 24/7. We've seen pharmacists staying open to make sure people get the medicines they need. We've seen people in pathology work shift after shift to make sure that COVID tests can be processed swiftly. We've seen politician after politician stand up and thank the heroes of the pandemic—the people on the frontline, the people that are the last defence, the medical profession, the scientists—and we rightly thank them. But we need to do more than just thank these people. We need to back them in.

Many people today will say how amazing the TGA is and how crucial it has been and continues to be to our health system in Australia. And that is absolutely right. We have an obligation to do more than just congratulate the scientists and the administrators that work at the TGA. We need to back them in. We need to support what they're doing. And we need to back in the Australian people, who have sacrificed so much in the last 12 months to get behind their state and federal governments to suppress the virus. They haven't been able to see family and friends, they have missed weddings and funerals and birthdays, they have had to talk to grandparents through windows at aged-care facilities and they haven't been able to leave their house for more than an hour in a day so that we can suppress the virus and save lives. We owe it to those people to do everything that we can to make sure that our community has confidence in the vaccine. We know that a proper rollout and penetration of the vaccine through the community is what we have to achieve to be able to carry on with suppression of this virus.

We know that the best way to protect the economy is to also deal with the virus. I know that the Prime Minister, the health minister and members of the government are outraged by what they see the member for Hughes saying on social media and in mainstream media interviews. That is why it is so disappointing to see all of these people just let him go. The standard you walk past is the standard you accept. For far too long, the Prime Minister of this country has walked past the outrageous behaviour of the member for Hughes. For too long, the Prime Minister of this country has let outlier backbenchers in his government daily go about undermining the work of our public health officials, the chief health officers and chief medical officers of this country. It has to stop. Why is it that the member for Hughes felt empowered to do a podcast with Pete Evans? Why is it that he feels empowered to go on the news and say that it's his right to undermine the efficacy of the vaccine? It's because the Prime Minister walks past and turns a blind eye to what the member for Hughes does. The member is undermining public health and he is doing a disservice to every single person in this country. We cannot have a member of this parliament, elected to be a leader, spreading antivaxxer, antihealth conspiracy theories, and have the medical practitioners in the government, let alone the Prime Minister of the country, do nothing to stop it. It is a disgrace. The free speech warriors in this government, who like free speech when it's from people they think are on their side but hate it every other time, appear to think that free speech applies everywhere in this parliament. They even gag debate on whether the member for Hughes should be pulled into line by the Prime Minister and should stop his dangerous actions.