Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Minister, the existing wording of section 19(1) already allows the TGA to approve the use of a drug that is not registered or approved in Australia, in the event of a shortage. That power has been used for 135 current approvals, and for 600 expired and lapsed approvals, for a total of 735 approvals of new drugs or versions of drugs in two years. Why do you need new powers when the existing wording is clearly no barrier to approval?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

Thanks for the question, Senator Roberts. The advice that I've been provided is that the amendment goes to the ability to be able to act in advance of a shortage arising—knowing that a shortage is coming towards us down the pipeline rather than being required to wait until the shortage actually arises. It will allow the government and the authorities to get ahead of shortages in relation to pharmaceuticals.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Thank you, Minister. Minister, can you provide an example of a situation where this new power would be needed because the old wording did not provide for that situation?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

Senator Roberts, I think I've explained the principle, which is that from time to time we know that shortages of pharmaceuticals do arise. They arise because of interruptions to global supply chains or, sometimes, an interruption in a particular facility's manufacturing capability. That disruption doesn't immediately translate into a shortage, but we know, logically, that it will at some moment. These provisions allow us to get ahead of that situation.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

My previous question was theoretical, to understand the process that informed the legislation. This question, Minister, is not theoretical: in what situation has the existing wording of section 19(1) failed to provide a good outcome for everyday Australians? Could you give me a real example, please?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

There are multiple shortages that are managed by the TGA, and we want to be in the best possible position in the future to be able to manage them as they arise.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Just one example, please, Minister—not a theoretical one, not a hypothetical; just one concrete example of where this has been needed in the past and was not available.

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

Senator, it's not my intention to trawl over previous decisions and circumstances, but it is the case that, from time to time, we can see in advance the potential for a shortfall, and we want to give the TGA the best possible opportunity to be able to intervene and make sure that the medicines that Australians need are available.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

That seems to be confirmation, Minister, that it has not happened in the past. There's no need for it.

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

That doesn't follow from the advice I've provided to you, Senator Roberts. There are shortfalls from time to time in medications that are important for Australians. The TGA presently acts to manage those and works very actively. We want to make sure that, in future, they have all of the tools available to them to be able to do that, and we consider this to be an important amendment that will assist the TGA in that task.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Minister, thank you. You say that there are examples, but you won't give me any, so let's move on. Under this new low bar for approval, a pharmaceutical company would be tempted to avoid applying for a regular approval, which is expensive and time consuming, when they could just have their drug waved through under a spurious scarcity rumour—not fact but pending scarcity. Minister, what safeguards are in this legislation to ensure that big pharma does not create a false scarcity story to avoid making a normal authorisation application?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

The TGA relies on intelligence; the TGA does not rely on rumours. The premise of your question is incorrect. It remains my position, as I've explained a number of times now, that it's really important that we are able to act when we are aware of a forthcoming shortage or the possibility of a shortage of critical medicines. Australians rely on the availability of these, and it's an important function that the TGA serves in protecting the supply chain.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Minister, this is getting to be disappointing. You keep telling me there are many examples and it's concrete, but I don't get anything. Let's move on. Minister, under this bill, is there a time limit for the approval, and, if so, can the approval be renewed at the end of that period, creating what is, in effect, a permanent approval where they just keep extending it?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

Senator Roberts, when you're speaking about an approval, which particular approval are you referring to? Obviously, the legislation canvasses quite a range of different approvals.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Any temporary approval.

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

The advice I am provided is that the approval, by its nature, is temporary and expires as the shortage is resolved.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

So, if the shortage is not resolved, is there a time limit for that approval to be enforced? If there is, can it automatically be renewed—in other words, granting a bypassing of the normal full regulatory approval process?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

I appreciate the senator waiting while I obtain advice. I want to give accurate information to the Senate. The advice I've been provided is that these are statutory criteria that need to be met for any approval, and the TGA would need to be satisfied that those statutory conditions were met. However, it is the case that, ordinarily, these circumstances resolve themselves, so we do see shortfalls from time to time, and they are generally resolved over time. Our interest is making sure that any short-term shortages or impacts on Australians can be managed and that the TGA has the tools to do so.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

So, Minister, is there a time limit and is it automatically renewed if the shortage continues beyond that time limit?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

The advice that I have is that the approval would be provided with a time limit. That doesn't prevent a reconsideration of the same questions, but it would be against the same criteria that I referred to in my earlier answer to your question.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

So it's highly likely we would just continue. The TGA has already approved certain drugs, including the product Pfizer sells as a COVID vaccine—their word. It's already been approved for full TGA approval based, according to the TGA, on the safety profile data experienced during emergency use authorisation. Minister, will this legislation provide yet another way big pharma can make an end run around Australia's longstanding authorisation process?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

No. That's a very leading question. The purpose of the legislation is set out in the explanatory memorandum and in other documentation around the bill, and there has been a Senate inquiry into the bill. Our objective is to make sure that Australians have the medicine that they need, even when shortfalls arise globally, and that we are in the best position to manage any consequences when we do see interruptions to global supply chains.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Of the 735 drugs granted authorisation under the existing legislation, how many are now subject to an application for full approval or have been approved based, according to the TGA, on the adverse events profile of the drug during approval under section 19(1) in the same way Pfizer's Comirnaty was?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

I am not in a position to confirm the numbers that you've cited in your question, nor do I have information about the numbers of applications on foot in various processes administered by the TGA. Perhaps you might like to think about another way of getting to the information that you're interested in.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

I will ask again and will try and break up the question: of the 735 drugs granted authorisation under the existing legislation, how many are now subject to an application for full approval?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

As I indicated to you, Senator, I don't have that information with me, nor would you expect me to. It's a very detailed question.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Okay, I won't continue with the other breakdowns of the question. Let's move on to the next question. Does a drug approved under section 19(1) also go on the Pharmaceutical Benefits Scheme and, if so, does the normal negotiation on price still occur, or do we just pay whatever the drug company wants us to pay?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

Thank you for waiting, Senator Roberts. I was seeking advice, again so that I can provide you with accurate information. The advice I have is that the standard process is for a medicine or product to be listed with the ARTG first before being considered by the PBS.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Thank you, Minister. The TGA have been enjoying unrivalled, unquestioned and unaccountable power since the start of COVID. Minister, why is the government extending the powers of the TGA again, with a bill that provides zero parliamentary oversight of the new powers?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

I don't agree with many of the propositions that are embedded in your question, Senator Roberts. I think I've been really clear about the purpose of the bill, or at least the elements which you're asking me about now. Your very first question was: why do we need these additional provisions and abilities for the TGA? The answer is: from time to time we see shortages arise, where interventions are required to protect the interests, particularly the health interests, of Australian consumers. We want to make sure that the TGA has the capacity to manage these kinds of shortfalls.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

Thank you, Minister. I appreciate what you just said; I don't agree with it at all, because the TGA has run roughshod over the people of Australia when it comes to health. They are not held accountable. We need to return, in my opinion, to the days when the department of health approved or did not approve a drug and then the department could be held accountable to the parliament. That's not the case for the TGA. It completely bypasses the parliament. So I foreshadow my amendment to introduce a provision to the existing legislation that any approval issued under this legislation must be by way of legislative instrument to allow parliamentary scrutiny. We, not the TGA, represent the people. The TGA has so many close contacts and close conflicts of interest with big pharma. It gets 96 per cent of its revenue from big pharma. Minister, why is there so little parliamentary oversight of our health bureaucracy?

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

Senator Roberts, I think you and I have different views about the level of oversight. The TGA is part of the department of health. The department of health appears regularly at Senate estimates. There are also a range of forums in which the parliament may ask questions about these issues, including, of course, in this place, in our own question time. Our government is committed to scrutiny, and I simply disagree with the proposition that you have made in your question just now.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

You're welcome to disagree, Minister. I'm sure that you welcome my disagreement. We saw the previous head of the TGA, Professor John Skerritt, retire from the TGA and, eight months later, get a job on the board of Medicines Australia, the big pharma medical lobby in this country. We also see that the TGA gets 96 per cent of its revenue from big pharma. That is a reason why we need to take the approval of drugs away from the TGA. Big pharma is not trusted, and, by association and due to their COVID mismanagement, we don't trust the TGA anymore. I move One Nation amendment (1) on sheet 3379 as circulated:

(1) Schedule 2, Part 6, page 22 (line 1) to page 23 (line 22), omit the Part, substitute:

Part 6 — Therapeutic goods approvals

Therapeutic Goods Act 1989

52 Subsection 19(1)

Repeal the subsection, substitute:

(1) The Secretary may, by legislative instrument, grant an approval to a person for the importation into, or the exportation from, Australia or the supply in Australia of specified therapeutic goods that are not registered goods or listed goods:

(a) for use in the treatment of another person; or

(b) for use solely for experimental purposes in humans;

and such an approval may be given subject to such conditions as are specified in the instrument.

Note: For variation of an approval for use of the kind referred to in paragraph (1)(b), see subsection (4B).

(1AAA) A legislative instrument made under subsection (1) must set out the reasons for the approval.

53 Subsection 19(4B)

Omit "by notice in writing", substitute "by legislative instrument".

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I would like to make a couple of comments on the contribution that Senator Roberts has just made in relation to his amendment to this particular bill. I probably would have a great deal of sympathy with Senator Roberts's position, particularly after the comment made by the government that they're committed to scrutiny. I don't think anything could be further from the truth, when we've seen the amount of times that transparency has been denied in this place. In fact, this morning we had a half-hour contribution about the refusal of this government to be transparent when it comes to the NDIS. So I certainly have a great deal of sympathy with Senator Roberts in relation to the lack of scrutiny of their actions that the government are largely prepared to allow this parliament and the Australian public over their time in government.

But, in saying that, I understand that one of the most critical issues facing Australia in recent times has been drug shortages, for a number of reasons, of medicines and treatments coming into Australia. As a legislature, whilst safety and efficacy are at the forefront of every decision we make in relation to providing treatments and access to treatments for Australians through the necessary processes that exist within the department of health—and that includes through the TGA—one of the things we must always do is make sure that there is quick access because we know that so many Australians rely on treatments.

When there are shortages, the government must be able to act with some haste to put supplementary or substitute treatments and medications in place to ensure that Australians are not denied the life-saving and life-changing treatments they often rely on. At no time should safety ever be compromised for Australians, but we do understand that many Australians rely on the agility of our health department and its agencies to do that. But we acknowledge the lack of scrutiny and the lack of transparency that have become a hallmark of this government.

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

I'd like to indicate the government's voting position. As I understand it, Senator Roberts's amendment seeks to essentially require certain decisions to be made by way of a legislative instrument rather than by notice of writing. The government consider that this would be unnecessarily burdensome and would deprive the TGA of the flexibility that is necessary to manage the health interests of Australians, and we won't be voting in favour of Senator Roberts's amendment.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

Senator Steele-John, were you seeking the call?

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

I may have a couple of questions, but not in relation to the One Nation amendment. I'm happy for that to be transacted and to then go back to questions on the bill.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

The question before the chair is that amendment (1) on sheet 3379, moved by Senator Roberts, be agreed to.

Lidia Thorpe (Victoria, Independent) Share this | Link to this | Hansard source

I move the request for amendment (1) on sheet 3372.

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

Thank you, Senator Thorpe, for your contribution in the second reading debate and, as I indicated in my response, your engagement with Minister Butler about this set of questions. As I said, as with the second reading amendment, the government doesn't support this request for amendment. We are working with counterparts in state and territory jurisdictions on our response to the independent National Review of First Nations Health Care in Prisons and we consider that those matters are best dealt with in that way. But we thank you for your constructive engagement on these questions.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

The question is that the request for amendment (1) on sheet 3372, as moved by Senator Thorpe, be agreed to.

Pauline Hanson (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

I wish to foreshadow my amendment on sheet 3372. Before that, I wish to speak to my amendment and what it means. It's basically asking for photo ID to be shown when you go to the doctor. Medicare, at the moment, is facing about $3 billion of debt a year through rorts that are happening. I have advocated before to get photo ID on the Medicare card. My amendment is basically to require people to show identification—your driver's licence, passport or other identification—that will prove that it's actually you attending the doctor's appointment. Why I say this is because in my first time in parliament, from 1996 to1998, I was advised, by the Federal Police, about the rorting that was going on in our Medicare system. People were coming across from overseas, using our Medicare system, and getting prescriptions, and then taking them back to their country and selling them on the black market. That was known to the Federal Police. They informed me about it. Nothing has been done about it.

There was another case where a gentleman had a friend visit from Macedonia. He took his friend's card. He got sick, and he ended up in hospital. He died in hospital. They believed this other fellow, who was an Australian, had died, but he came forward to say 'no', that he had loaned his card to his friend. There were no charges laid. We now have 100,000-plus people who are illegally in Australia, overstaying their visas. We have a number of foreign students in Australia, which has expanded out to 750,000. These foreign students have friends and family also, so they can take their family or friend's Medicare card and abuse our system. There are also doctors that are prescribing medication to these people—it shouldn't be. That's an added cost to our PBS that we, the taxpayers, are funding. We shouldn't be funding this at all.

Even doctors are falsely claiming funding for appointments they did not have. This is an ongoing problem that we have in Australia. Also, these people are not paying the right price to go and see it—they would go to bulk-billing. Of course, the government tell us they are going to raise the bulk-billing rates to 90 per cent in just a few years. Well, I'll believe that when I see it, because I don't believe it's going to happen.

Also, with the rising costs for the doctors in rent and other things that are happening, they can't afford to give bulk-billing. They're not meeting their costs or overheads of staffing, rates and electricity that are needed to run their practices.

With Medicare as well, the figures show that we're going to be 10,000 doctors short within the next five to six years. How can we keep giving decent health care to Australians? I know that a lot of people are saying it takes them two-plus weeks to get in to see a doctor—at least. Some are taking even longer than that. Doctors have closed their books; they're not seeing new people. Our hospital system is being overrun with people going to the emergency section because they can't see a doctor.

What is happening here is an absolute disgrace. All I heard from the Labor Party during their campaign was about this Medicare scare. That's all you've put out there. You said you were going to open up 24/7 bulk-billing. It never happens. You only had a couple that opened 24/7, because you can't get the doctors. What you're also doing is taking doctors from general practices to put them in the bulk-billing Medicare centres—you say you're looking after the public—but all they are is first responders. A patient sees that doctor once, but they don't go back to them. They have to go back to their GP.

What's happening then? All these doctors are leaving GP practice because they're getting paid better in the bulk-billing practices that Labor are setting up, and there are no doctors to go back to in these communities because they've left. You're causing more of the problem that you're supposed to be sorting out with Medicare, which is rising in cost. I just don't see. You haven't got the answers for it. The hospitals are overrun. You haven't got beds that are provided for the public at all.

My proposal here is for people to be required to show identification; there's nothing wrong with that. Show the public that you are fair dinkum about saving the taxpayers' dollars here and not allowing people to rip off the system. The least the public could expect from the government is that you will not provide services to people who are ripping off the system. If people want to go and see a doctor, fair enough. If they are not an Australian that's entitled to this service, then they should pay the price for it. These people are supposed to come here. They've got their insurance. They should be able to pay for medical care, but they expect the taxpayer to pay for it.

This is something that I've raised for years, time and time again, yet you do nothing about it. You think it's an endless pot of gold out there for the public to pay for. It's the same with the NDIS and Aboriginal industry. I could keep going on and on about the waste of money that we have out there. You are not reining in the cost to the Australian taxpayer. I am calling for support for this amendment. I invite the government to prove to the Australian taxpayers that you are fair dinkum about reining in the rorting that is going on. It needs to be stopped. I move my amendment on sheet 3373:

(1) Page 40 (after line 4), after Schedule 3, insert:

Schedule 3A — Medicare benefit not payable unless government photographic identity document provided

Health Insurance Act 1973

1 After section 19C

Insert:

19CAA Medicare benefit not payable unless government photographic identity document provided

(1) A medicare benefit is not payable in respect of a professional service rendered to a person, unless the person provided a government photographic identity document at the time, or as soon as practicable after, the service was rendered.

(2) In this section:

government photographic identity document means an identity document providing photographic identification of a person that is issued by the government of the Commonwealth or a State or Territory.

Jenny McAllister (NSW, Australian Labor Party, Minister for the National Disability Insurance Scheme) Share this | Link to this | Hansard source

I'll quickly indicate that the government does not support the amendment. In 1984, we introduced Medicare. You're right, Senator Hanson, we will continue to defend Medicare and to protect it, because it's based on a simple promise, which is that, if something goes wrong—if you get hurt, if you get sick or if you need help—you won't be on your own; Medicare will be there for you. Our view is that we will get on with the job of strengthening Medicare. You really should only need your Medicare card if you need to see a doctor—not your drivers licence or your credit card but your Medicare card. It is on that basis that we oppose the amendment.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Whilst we won't be supporting Senator Hanson's amendment, because we would have liked the opportunity to have had more time, we do understand the intent she is trying to achieve here. That is making sure that we minimise the amount of fraudulent activity that occurs in Medicare. That is absolutely to be commended.

But Senator Hanson also makes some very good points about the fact that, under this current government, Australians are being incredibly misled about Medicare. Nothing could be more egregious than the Prime Minister waving around his Medicare card during the election campaign, trying to con Australians into believing that that was the only card that they needed when they went to the doctor.

Australians know a very different story. They know when they go to the doctor, because it hits them in the hip pocket. They don't just need their Medicare card. Under this government, the amount that they are paying on their credit card for out-of-pocket expenses has never been higher. It is the highest amount that has ever been paid by Australians to visit their doctor under Medicare. I think it is incredibly disingenuous for the Labor Party to come in here and pretend that Australians don't need anything but their Medicare card, when they know that the truth is it has never been more expensive.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

It being 1.30, the Senate must move on. As at 1.30 pm, the committee reports progress to the Senate. We now move to two-minute statements.