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

I'm pleased to speak on behalf of the Labor Party in relation to the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021. The bill flows from the conclusion of the latest round of strategic agreements between the Commonwealth on the one hand and, essentially, the pharmaceutical industry represented by Medicines Australia, which represents the innovator part of the industry, and the Generic and Biosimilar Medicines Association—GBMA—which, as the name of the association indicates, represents the generics and biosimilars part of the industry.

This is a process that has been underway now for some time. It started in the latter part of the first decade of this century, largely in response to the projections contained in the first Intergenerational report, which was published by then Treasurer Peter Costello in 2002. It projected that PBS costs would climb quite dramatically over the 40-year period that each of the IGRs contemplate. As I recall, of the increase in Commonwealth health costs across the spectrum of responsibilities the Commonwealth has in health, 70 per cent of the increase in Commonwealth obligations would come from increases in the PBS. At the time there was all manner of breathless pieces of commentary about the PBS being unsustainable and having to be reined in, lest the whole of the Commonwealth health budget fall down because of the burden on it.

The process that has now been undertaken through governments of both political persuasions, including the Rudd and Gillard governments, to come to an agreement that balances the viability of this critically important sector, to bring medicines that are often developed overseas—this is a global industry—to Australian patients and to ensure that Australian patients have a ready, dependable and affordable supply of the best medicines in the world is, on the one hand, a key objective. On the other hand, fiscal sustainability has been essentially a tension or a balance sought to be achieved through a series of strategic agreements. This is the latest one, which follows a lengthy negotiation between the Commonwealth, led by Minister Hunt, and the industry, represented by those two associations.

The bill implements two critical measures contained in the agreement; I'll come to what those measures are. The agreement contains a number of other very important measures that are not reflected in this bill, because they will largely be measures implemented through the executive government and the industry. I will talk very briefly about one or two of those measures, because they give important context to the important but largely technical matters included in this bill. Of very substantial importance is the government agreeing to the first independent review of our health technology assessment processes. It's quite clear that, with the enormous advances in medical technology we are living through, we are living through a turbocharged period of discovery not just in health but in a whole range of sectors of society and the economy, characterised by the harnessing of big data not only in health and medical research and technology development but also in genomics and the development of this extraordinary generation of precision medicines, new diagnostic technologies and so on and so forth. This is quite expensive but incredibly exciting, because it's giving us avenues to treat and, in some cases, cure conditions that not too many years ago were thought untreatable—or, if they were treatable, were thought to be largely incurable. This is a wonderful period we're living through.

I heard the member for North Sydney and, on our side, the member for Macarthur table the latest report from the House of Representatives inquiry into access to medicines. They talked about the horizon that awaits us, where, as the member for Macarthur indicated, very orthodox traditional technologies for cancer treatment, like chemotherapy, may well—and we hope so—soon become a thing of the past, replaced by precision medicine that targets the cancer in a very precise way, without doing the extraordinary damage to surrounding tissue and cells that we know chemotherapy does. This is incredibly exciting.

But so many of these new treatments don't fit neatly into the silos which are reflected in our assessment, approval and reimbursement systems. Those systems are largely set up around the idea that something is a therapeutic good, usually a medicine, or a service, a diagnostic technology or a medical device, each of which largely have their own assessment, approval and reimbursement systems. The trouble is that treatments now tend to blur those distinctions such that you might end up with something called theranostics, which is a combination of diagnostics and therapy, not fitting neatly into those traditional Commonwealth systems but giving patients, for example, with neuroendocrine cancer the most extraordinary opportunities for treatment.

This health technology assessment review has rightly been welcomed by patient groups in particular but also by the broader industry as well and certainly by the opposition. It commences next year. It's to be concluded in 2023. The inquiry report was delivered by the member for North Sydney and the member for Macarthur, and the inquiry was conducted by both of them with a great deal of energy and a real spirit of cooperation and bipartisanship across the aisle that has garnered very impressive reviews from industry and patient groups. These two things together, along with a review of the national medicines policy, I think set out a really exciting pathway to the future.

It will be incumbent on whatever government ends up holding power after the election largely to steer those processes through. That really is the important guts—if I can use that technical term!—of these strategic agreements. They are an opportunity to bring our assessment, approval and reimbursement systems into line with what's happening in the real word. It's an incredibly exciting period of discovery that we're living through.

Having said that, though, and having mapped out, hopefully, what some of the more exciting, sexy parts of the agreement are, there are, as usual, the more technical, bureaucratic measures contained in this agreement which are very worthy and supported by the opposition. As I've said a number of times in public fora and in this place, we are a party of government. We take the view that agreements concluded in good faith between the Commonwealth government and industry, as in this case, must be respected by an incoming government, if we're lucky enough to be an incoming government next year. Our approach to the conclusion of this agreement, which we've indicated publicly we support, extends to our support for this bill, subject to a second reading amendment which I foreshadow that I will be moving at the end of my remarks.

This bill covers two important measures contained in the strategic agreements. The first is to amend the price reduction system that has been a feature of the strategic agreements going back to the first decade of the century, the decade before last, to ensure that some anomalies are fixed in favour of taxpayers and the budget, particularly through catch-up statutory price reductions, which I will talk about. Secondly, the agreements in this bills also put in place measures to deal with the insecurity of supply of a range of medicines that had already started to become an issue in Australia but which has been greatly exacerbated by the supply chain shock that we've seen through COVID. I might deal with that measure first of all.

At the moment, there are around 263 medicines that are listed by the TGA that are experiencing shortages in Australia, with a further 54 medicines that have anticipated shortages. So well over 300 listed therapeutic goods—listed medicines—in Australia do not have secure supply. As local members on both sides of the House, I'm sure we have all been receiving substantial feedback from patients, constituents and pharmacies about the difficulty they have been having—some of that was already happening before COVID—accessing supplies of very standard, important medicines: medicines for cardiovascular disease, diabetes, epilepsy, high cholesterol, pain management—particularly for severe pain, as well as a range of medicines for mental health conditions, including depression, bipolar disorder and schizophrenia. These are obviously very important issues for the delivery of good health care to the Australian community.

This agreement contains a number of measures to, essentially, put in place an obligation on industry to guarantee security of supply of a range of medicines, particularly those that are at risk of supply shortage—a security of supply of four to six months stockholding. This is a measure that we support and that we think is a proportionate, measured response to the shortages we've seen, particularly over the last two years, but, as I said, some of which predated COVID. It's a measure we welcome.

Regarding return for the obligations that the industry has taken on through the signing of this agreement—the medicines supply guarantee they make—I make the point, firstly, that this is largely a supply guarantee that will fall on the genericised medicines, because they are the medicines that are usually subject to insecurity of supply. In return for that guarantee, the government has agreed to a modest price support for those medicines. This itself, frankly, should help ensure a greater willingness on the part of global industry to ensure that the Australian market is properly supplied. So that is the first technical measure contemplated by this bill, a measure that we support.

The bill also implements a number of important measures designed to deliver price reductions for medicines. As I said, a system was put in place some years ago that has really delivered very substantial budget savings for Australian taxpayers. These new measures include catch-up price provisions that deliver price reductions for medicines that have thus far avoided price reductions commensurate with what we would expect in the functioning of a competitive market. It is through these catch-up price reductions that the bill delivers around $1.9 billion in savings to the PBS, which will be reinvested in the PBS through new listings.

The full schedule of statutory price reductions is very large and complex—far too large and complex for me to detail in this speech—but it is worth the House noting some of the more prominent of those details. These reductions will ensure that on the 5th and 10th year anniversary of a drug being listed on the PBS the drug will see a five per cent price reduction on each of the two anniversaries. This price reduction increases to over 26 per cent on the 15th year anniversary of a listing. In 2027, towards the end of the agreement, this 26 per cent reduction for the 15th year anniversary will increase to a 30 per cent price reduction—a very substantial saving to taxpayers, which will be reinvested in new listings on the PBS. The bill maintains a first new brand price reduction of 25 per cent, which applies when the first new brand—which will usually be a generic—that is bio-equivalent or bio-similar to and has the same method of administration as an existing brand of drug is listed on the PBS. Again, that is a substantial savings. The five-, 10- and 15-year anniversary statutory price reductions only apply if a drug has no competitors listed on the PBS and, as a result, has not been subject to a first new brand price reduction.

Some drugs have been listed on the PBS for over 15 years and have not yet been subject to price disclosure reductions that are designed to ensure the PBS can adjust and see those decreasing costs over time. These drugs will now be subject to catch-up price reductions equal to the cumulative statutory reductions that would have applied over the period of their listing. That means that, for a drug listed for 15 years that thus far has not seen any price disclosure reductions, we will see a price reduction of almost 37 per cent from 1 April 2023. It should be noted though that the 25 per cent first new brand price reduction will not apply if the 15-year anniversary price reduction has been applied. Again, we welcome the agreement between industry and the government on these catch-up price reductions. We think they're a proportionate, measured response to the circumstances surrounding some of those drugs that have not yet been subject to the price disclosure reductions over 15 years, again seeking to balance that need around access to new medicines for Australian patients with the sustainability of the PBS elements of the budget.

There have been some issues raised by areas of industry and some patient groups which I want to put on the record and that I know the minister is aware of and is responding to. There are some nonmembers of Medicines Australia who have expressed concern to a number of fora, to the opposition and, I know, to the minister about slow-release drugs for a range of disorders, including opioid dependence, that will be subject to statutory price reductions under this bill, even though the slow-release versions of these drugs are quite novel and have not been supported by the PBS for the statutory period of 15 years.

The intent of this bill, which we support and understand the government has, is to give effect to a broad objective in ensuring the sustainability of the PBS while safeguarding medicine supply for the Australian population. That includes making sure that statutory price reductions do not have an unintended consequence that results in the withdrawal of supply of important medicines from the Australian market. We have a strong view, and I imagine the government shares it, that statutory price reductions should not be allowed to undermine medicine supply.

As a result of that shared objective as I understand it, we note the important role that ministerial discretion has in determining how price reductions are applied in order to ensure that supply of medicines is maintained along with, connectedly, the financial viability of medicine suppliers. We know that the government shares that view, and to that effect we understand that the government has committed to bringing forward an update of the ministerial discretion guidance material and to engage companies that are potentially affected in that process of an update. In particular, I am referring to the companies that I know have been in communication with the minister, as they have been with me and my office. I welcome that commitment from the minister and expect that will be delivered in good faith.

As I said, this is an important agreement that has been struck between the government and the pharmaceutical industry. It follows a series of agreements that have been struck now for some years. It's clear that the predictions contained in the 2002 IGR around increases in the PBS budget have not come to pass. We're only halfway through the 40 years that then Treasurer Costello was looking at at the time.

But it is a very different picture to the one that was painted in the 2002 IGR, and that in part is due to the discipline that's been introduced into market pricing through a series of these strategic agreements. I think it also reflects the fact that those projections from Treasury about PBS costs were, to describe them generously, probably quite heroic. I commend this bill to the House and indicate the opposition will support it subject to a second reading amendment, which I now move as follows:

T hat all words after " That " be omitted with a view to subs tituting the following words:

" whilst not declining to give the bill a second reading, the House urges the Government to do more to ensure Australia's p harmaceutical industry can provide new jobs, medicines and investment into Australia. "

Rick Wilson (O'Connor, Liberal Party) Share this | Link to this | Hansard source

Is the amendment seconded?

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

I second the amendment and reserve my right to speak.

Julian Simmonds (Ryan, Liberal National Party) Share this | Link to this | Hansard source

I rise this afternoon in the House to support the substantive National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021. I speak on this bill, as members in this chamber probably already know, with a background as the son of not one but two pharmacists. Both mum and dad were, and still are, pharmacists. They are proudly very active in the industry. For a number of years they ran a very successful small business—a pharmacy, as you can imagine—in the city of Brisbane, in the CBD, branching out to own a second pharmacy at one point.

When I was growing up, like all kids of small-business people, I spent my holidays, over Christmas and at other times during the year, working in the business. This gave me an incredible firsthand appreciation of just how vital the PBS is to our nation. Having access to affordable medicines makes our community stronger and improves the quality of life for Australians. It should never ever be taken for granted. It can be taken for granted—members on the other side of the chamber have shown that—but I'll get to that later. It should never be taken for granted.

I saw firsthand how important the PBS was for people from all walks of life, from those families walking into the pharmacy with their colds and flus, or their rashes that mum and dad would diagnose and then provide a product for, through to putting together Webster packs for elderly patients. Webster packs are for packaging all of their medicines—of which there can sometimes be quite a lot and involve some significant conflicts if you're not careful—into a pack where they can pop it out day by day and keep track of their medicines. It went all the way through to methadone patients who had significant addictions and struggles, often mental health struggles, who would attend the pharmacy to get their regular methadone to help kick that addiction.

No matter where you sit in the spectrum of life, you will need the PBS. You will need pharmacies, for that matter, and pharmacists, but you will need the PBS. That is why I am so passionate about ensuring that it is fit for purpose and that it is doing what it's designed to do, which is to assist Australians. I am proud to be part of a government that, since coming to government, has listed over 2,800 medicines worth $13.9 billion to the PBS. We hear time and time again from the health minister, particularly during question time, about how the drugs that are listed help individuals. He is very good at providing the stories of individual families who are affected by these medicines being listed: people suffering cancer, heart disease, epilepsy, spinal atrophy, multiple sclerosis, cystic fibrosis, severe asthma, severe osteoporosis, chronic migraines and many other conditions.

For people, particularly those who have a chronic condition, these new medicines can cost many hundreds of thousands of dollars. For people who have a chronic condition, if these medicines weren't listed on the PBS they would be out of reach on a regular basis from these Australians' acces But, because they are listed on the PBS, instead of costing thousands of dollars per treatment per month, or maybe per week, they're available for $6.60 for a concessional patient or $41.30 for general patients per script. Without the PBS, those Australians would have a lower quality of life, would have more suffering and, in many cases, we'd see lives cut far too short.

While there's no way to quantify the full impact that the PBS has across Australian society, we know that this is an investment worth making in Australians, many of whom have those chronic diseases that they need relief from. Of course, to be able to add so many medicines to the PBS you need a strong economy, and that's what the coalition government has been able to deliver. Prior to COVID, we were listing medicines on the PBS at a rate on average of one per day. That is an incredible achievement, because, as the previous Labor speaker said—and I'll give him credit for this—we are living in an age of incredible medical advancement. We have incredible opportunities that medicine and medical science is providing to us to advance the drugs that we have available and to tackle some of these more chronic diseases. But to be able to take up the opportunity of those new drugs when you have a drug company lobbying the government saying: 'We have this new drug. It's ready to go. There are this many Australians who would benefit from it, who are currently suffering from a disease and we can improve their quality of life, but, because of the IP and the research and the technology we've had to invest in it, it's going to cost them many thousands, tens of thousands, in some cases, hundreds of thousands,' you want your government to be there with the economic circumstances in place so that they can take up that investment as soon as it is possible so Australians don't have to wait. The economic legacy of this coalition government has been that we have been in a position to take it up. Where the PBS independent authority have recommended it, it then goes to a period of negotiation with drug companies and, once a price has been agreed on as part of that negotiation, we're in an economic position to list it.

When I spoke earlier about the fact that that can never be taken for granted, we know what happens when it is taken for granted, because, as much as the PBS is one of the great Australian achievements that we have in place to support a broad cross-section of Australians, it is a great myth of Australian politics that the PBS is somehow all enduring, that it's eternal and it can't be wilted away. Well, it can. It can wilt if you neglect it. And that's what we saw under the previous Labor government, where they literally had to issue budget papers to say that due to financial constraints—that they themselves had imposed with their reckless spending!—they were no longer able to list drugs on the PBS as they came up. The practical outcome of poor and reckless financial management is that you can't list these drugs when they come up and, at the end of the day, that means Australians with chronic diseases, people who need it, suffer. They suffer. I don't ever want to be in that position again as an Australian society and I know that, as a coalition government, we won't allow that to be in place. But Australians need to remember that the PBS is not something that, by signing up to these bills, Labor can claim is all enduring and have no worry about, because we've seen, when they have had their hands on the financial levers of this country, when they've had the opportunity to do more than just talk, as they do a lot in this chamber, when they have the opportunity to undertake the action to preserve the PBS, they haven't been able to do it because they've prioritised other spending.

This government is a consultative government. That's why I'm pleased to support the substantive bill, which is all about the new agreement that has been struck with Medicines Australia. It's a result of significant consultation with the medicines industry to ensure that sustainability of the PBS long-term. So, when we went into the negotiations as a government, we had two overarching goals. We wanted Australia to continue to gain access to those brand new breakthrough medicines as early as possible, as early as we can negotiate. The other goal that we have in mind that we've achieved with this agreement is to deliver a far more robust and uninterrupted supply of medicines needed and used by everyday Australians. There are a lot of things that the COVID-19 pandemic taught us, but in particular we learnt about the vulnerability of some of our supply chains, about how these unforeseen events can truly bring global supply chains to a halt. We can't afford that to occur when it comes to these medicines that are either life-saving or treating chronic diseases.

The industry agreements will achieve this by securing commitments from the medicine industry which will result in substantial savings that we can then go ahead and reinvest into the PBS to list more medicines. Through improved statutory price reductions, savings can be reinvested in the PBS to make it even more sustainable and to create more headroom for us to list new life-saving drugs. The reforms of this bill see better supply, reduced cost and greater access to new medicines. These reforms are critical to ensuring the continuity of access that is so important for the proper treatment and management particularly of chronic conditions.

Increasingly, global shortages are interrupting supplies of medicines. In 2019 and 2020, brands of over 500 PBS items were affected by medium to critical impact shortages, with brands supplied by manufacturers for $4 or less the most susceptible to global supply chains. This includes medicines for common health conditions such as high blood pressure and diabetes and medicines for mental health conditions such as depression, bipolar disorder and schizophrenia. These reforms, as agreed with the medicines industry as part of the agreement that forms the basis of the substantive bill, will ensure that manufacturers are better placed to compete for supply of these medicines in the global medicine market and hold greater reserve supplies of at least four to six months of stock in Australia to buffer the Australian market when interruptions occur. If a global pandemic occurs again, like we have seen with COVID-19, this agreement will help ensure that we have that immediate to medium-term stock in place so that we can deal with those supply chain issues. From 1 July 2023, additional stocks will be held for over 600 PBS items, including most brands that have an approved manufacturer price of $4 or less, because, again, these are the most common medicines used for chronic diseases that people can't afford to skip or they go back a number of steps in the treatment process. These reforms will be critical to ensuring the continuity of access.

The other important goal of the agreement is harvesting savings so that we can reinvest them in other PBS medicines. The new savings from improved statutory price reductions, which will be reinvested in the PBS, will ensure that the reinvestment will allow for some headroom—a five per cent price reduction at the five-year anniversary of a drug listed on the PBS; a five per cent reduction on the 10-year anniversary of a drug listed; and a 26.1 per cent price reduction at the 15-year anniversary of a drug listed on the PBS, which will increase to 30 per cent in 2027. These are significant reductions in the headroom of PBS medications that can be reinvested to ensure that our PBS remains sustainable going forward, as we have an ageing population who will draw more on those medicines already listed on the PBS, and that can be used to add new medicines. These reforms will generate net savings. To quantify, there will be net savings of approximately $1.9 billion over the terms of the agreement, which will be reinvested.

Medicines Australia and the Generic and Biosimilar Medicines Association have committed to this bill. There was a significant amount of consultation that went into the bill, and there is support for greater security and supply of medicines. We've also received support from the Pharmacy Guild of Australia, the Australian Medical Association, the National Pharmaceutical Services Association and the Society of Hospital Pharmacists of Australia.

As I said earlier, together with the industry, as you can see from the broad support from across industry for this bill, we are going to continue to strengthen our health system. We are going to continue to make sure that pharmacists like my mum and dad have a more reliable supply of medicine so they can ensure that those who rely on medicine are not disappointed and so that those who rely on it for their treatment plan will always have a constant supply. We are going to make sure that we continue to list these drugs when they become available—because we have created the economic circumstances that allow us to do that through good and proper financial management—so that we hear fewer of these stories from sufferers of chronic disease. I am sure many MPs hear stories in their offices from families who are doing it incredibly tough, who can see the light at the end of the tunnel—they can see the drug that's going to drastically improve quality of life for a member of their family—but, because of the price, because of the IP that has had to be put into it and because of how new it is, it's just out of reach. It is with great pleasure that, as a member of the government, I can play a small role in helping to ensure that that gap is minimised and they can get access to a life-saving drug. Again, I pay tribute to the health minister, Greg Hunt, for all the work he has put into this legislation, as well as other stakeholders who have brought it to fruition.

Anne Aly (Cowan, Australian Labor Party) Share this | Link to this | Hansard source

The National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021 is the product of some fairly lengthy negotiations between the pharmaceutical industry and the government. What we have before us with this bill, as the member for Hindmarsh and shadow minister for health spoke to earlier, is something that can have bipartisan support. Certainly we on this side of the chamber support the bill and where it has landed in these negotiations. The enhancements in the bill are estimated to generate savings to the PBS of around $1.9 billion over the life of the agreement. In particular, Labor welcomes the reinvestment of those savings into the PBS to enable the supply of new life-altering and life-saving medicines in Australia. The bill will also, quite importantly, address the issue of medicines that have not seen price reductions through catch-up statutory price reductions and will see measures to ensure the supply of medicines is protected through stockholding and obligations.

I want to take some time today to talk about some life-saving medications in Australia and to specifically talk about the cases that have been brought to me as the member for Cowan and to express my advocacy for some of those life-saving medications to be included in the PBS. In relation to the $1.9 billion in savings over the life of this agreement, if consideration is given to reinvesting those savings into looking at listing new life-saving medicines, perhaps the government might consider the cases that I am bringing forward here for Cowan residents and their access to life-saving medication.

The previous speaker talked about constituents coming into our offices and telling us their stories of access to medicines, whether for themselves or for members of their family. In some of the cases that I will talk about, it is for children. He said that it's great when they can see a light at the end of the tunnel. Unfortunately, for the cases that I present here today, there is no light at the end of the tunnel. I pay heed to the parents of the children living with chronic health conditions, and the adults who are doing so, who continue to advocate very strongly for changes to the PBS in order to ensure that they do have access to the medicines that prolong their life, that give them a better quality of life or that are a cure for their chronic diseases.

Last week in this House, the member for Macarthur presented a petition signed by thousands of people relating to a drug called Trikafta, which is a cystic fibrosis drug. I have a very good relationship with the cystic fibrosis community in Cowan and throughout Western Australia, and I specifically want to pay heed to Taryn Barrett, who is a very vocal advocate for people with cystic fibrosis. Her son, Connor, has cystic fibrosis. I've met Taryn and Connor on a few occasions and can't speak highly enough of Taryn's advocacy.

On the drug Trikafta, the pharmaceutical company that developed Trikafta, Vertex Pharmaceuticals, applied to the PBS to make it available for Australian sufferers of cystic fibrosis. Currently, the drug costs Australian patients around $300,000 a year. I don't know anyone who can afford $300,000 a year on a life-saving drug to keep their child alive, to give their child a quality of life and to prolong their child's life. Going through my Rolodex of friends, acquaintances and people I know, I cannot name a single person who can afford $300,000 a year to spend on a drug like Trikafta, but that's how much it's costing Australians living with cystic fibrosis at the moment.

Vertex applied to the PBS to have Trikafta listed. The PBS made it available only for people with a certain mutation of cystic fibrosis. The pharmaceutical company Vertex hasn't accepted that recommendation, because they argue it would actually exclude 80 per cent of cystic fibrosis sufferers. Taryn Barrett, who I mentioned earlier, is a WA woman and an advocate for people with cystic fibrosis. Her son, Connor, has cystic fibrosis. She said that there were almost 400 patients with the specific mutation who would have benefited from Trikafta going on to the PBS, who could receive help from Trikafta going on there. But there are 1,800 patients in Australia, including her son, who would miss out. In other words, the decision by the PBAC to recommend that Trikafta only be available to cystic fibrosis patients with a specific gene mutation would help 400 patients but would mean that 1,800 patients would miss out.

What does that mean for someone like Connor, and what does that mean for someone like Taryn, his mum? Taryn says it means that people are getting irreversible damage and people are dying, and it's not acceptable in a country like Australia. A treatment like Trikafta would mean that Connor would be able to grow old. Currently, his life expectancy is around 38 years.

Another of my constituents, who I was honoured enough to meet at a cystic fibrosis fundraiser and who I've become good friends with, Adam D'Aloia, is an adult who has lived with cystic fibrosis all his life. Through him I've learned so much about how cystic fibrosis affects the quality of life of those who suffer from it. Adam himself was the recipient of a double lung transplant and, because of that transplant, has been able to continue surviving, basically.

So Trikafta is one drug that I would hope, with the savings to the PBS and the measures to be brought about by this bill, we could look at funding, putting onto the PBS and making available to sufferers of cystic fibrosis, be they adults or be they children, to prolong their lives and give them a better quality of life. They deserve this. Cystic fibrosis is a terrible, terrible condition. It disrupts life. It disrupts work. It is so disruptive and so intrusive into an individual's life. Anything that we can do to improve the quality of life, the wellbeing and the longevity of people living with cystic fibrosis, we should do our utmost.

There is a second issue that I want to speak about. I hope this bill may give that light at the end of the tunnel for those who are living with type 1 diabetes and who do not have access to continuous glucose monitors. Earlier this year I met with Madison Lee, who lives in my electorate. Madison's brother had type 1 diabetes and tragically passed away in his sleep as a result of nocturnal hypoglycaemia. Madison's brother was just 24 years old, and, at 24, he was no longer eligible for a continuous glucose monitor. If Madison's brother had retained continuing eligibility and access to a continuous glucose monitor it would have saved his life. He would be alive today. The fact is that for someone who is 24 years old—he was an apprentice, so he wasn't on a high income—the thousands of dollars it costs to get access to a continuous glucose monitor is prohibitive. There are so many young people in their 20s who are living with type 1 diabetes and are no longer eligible for continuous glucose monitors who are putting their lives at risk because they can become eligible for a CGM, a continuous glucose monitor, if they have are hospitalised with a hypoglycaemic incident. So many of them are putting their lives at risk in order to have access to those monitors, which can save their lives.

I also met with a constituent, Mark Smith, who's been living with type 1 diabetes for 34 years. He came to see me because, like 60 per cent of people living with type 1 diabetes, he does not have access to life-saving and life-changing CGM technology. He's spending thousands of dollars a year to access CGM, and it's putting a strain on him, it's putting a strain on his family, it's putting a strain on his finances. It doesn't have to be that way.

Larissa, another constituent who also suffers from type 1 diabetes, is faced with costs of around $6,600 a year for a CGM, and she simply can't afford to keep up the cost of the continuous glucose monitor. She says, 'I am now in a crazy situation where if I choose to work a little bit less I will actually be financially better off because the burden of the continuous glucose monitor or flash glucose monitor would be subsidised.' Larissa wants to work, she wants to lead a normal life, she wants to contribute and work full-time, but doing so comes at a cost for her—that cost is the cost of having to fully subsidise, fully pay for, the continuous glucose monitor, which she simply can't afford.

I've talked about two examples—Trikafta and continuous glucose monitors. I know that every person in this House has heard stories from the families of individuals and individuals who have been living with some form of chronic illness or chronic disease who are struggling to pay for the medications they need. As the previous member said, we are incredibly fortunate in this country to have a PBS and to be able to subsidise some of those important medications for people to ensure their quality of living, to give them a better life, to give them a longer life and, hopefully, to cure their illness, whatever that illness might be.

I stand here because I want to support this bill. I think it is a good bill. As the member for Hindmarsh, the shadow minister for health, said, Labor does support this bill. We want our PBS to be better. But we also want more medications listed on the PBS for people for whom access to those medications would literally mean life or death, better quality of life and more longevity.

In closing, I support this bill, I support the measures that are contained in this bill. When considering the $1.9 billion of savings over the life of this agreement I urge the government to consider the medication that I mentioned here today, Trikafta, and extending the eligibility for the continuous glucose monitors, access to which will help to prevent avoidable deaths from type 1 diabetes. In the case of Trikafta, for someone like Connor to be able to live a long and healthy life means the world. It means the world to him, it means the world to his parents, it means the world to his community and it means the world to me too. I want to see Connor grow up. I want to see him have grandkids. I might not be alive by the time he has grandkids—and hopefully I'll get grandkids before he has grandkids!—but I want that for him and I want that for Taryn and Connor's family. I know that every member here wants that for every one of their constituents, too.

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

I rise to talk on the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021. Australians view the Pharmaceutical Benefits Scheme or PBS, as it's known, a bit like the way people in England view the NHS. It is something that people know, that they care about and that they trust, and they want their government to deliver the best PBS possible. That is because every Australian knows that at some point in their life they may have to rely on the PBS, and we know that many millions of Australians currently rely on the PBS. The Pharmaceutical Benefits Scheme serves to give Australians affordable access to quality medicine. It is something that everyone in this House should be proud of. The PBS is being supported by this government but has been supported over many, many years by many, many governments in Australia. Importantly, since this government came to power in 2013, nearly 2,800 new medicines have become available through the PBS. They are all government subsidised to ensure that the health of the citizens of our country is maintained.

The amendments in this bill reflect the new five-year agreements with Medicines Australia and the Generic and Biosimilar Medicines Association. These agreements seek to ensure Australia has a strong supply of medicine, with Australians able to access breakthrough medicines as early as possible. These new agreements that the government and the medicines industry have co-developed as a comprehensive package of reforms for the PBS will ensure that Australians can continue to gain access to new breakthrough medicines as early as possible but also deliver a robust and uninterrupted supply of medicines needed and used every day by Australians. It will just as importantly keep the PBS on a long-term sustainable footing. The industry agreements will achieve this by securing commitments from the medicines industry which will result in new savings from improved statutory price reductions which will be reinvested in the PBS, as they should. This reinvestment will in turn help to make headroom on the PBS for listing new medicines. This is very important because we need to get the balance to enable headroom to be provided so that we can get new drugs onto the PBS.

This bill will see patients save on average due to the decrease in price of a large number of PBS medicines. The reforms are expected to save nearly $2 billion over the five-year remit and will target Commonwealth investment towards securing a strong supply of commonly prescribed medicines that have suffered supply chain issues in recent years. Moreover, this bill guarantees over $5 billion of new investment in PBS medicine listings over the lifetime of the agreements to 2027. It seems like an odd year to say, 2027; it's just around the corner, though! This commitment will help guarantee that the government can list new medicines as recommended by the Pharmaceutical Benefits Advisory Committee as and when they become available and approved.

The bill will reinforce a strong supply chain to ensure that Australians are not left struggling to find the medicines they need. We all know we have been through a pretty dramatic COVID pandemic. Through 2019 and 2020, over 500 medicines listed on the PBS wrestled with medium to critical impact shortages, particularly medicines sold for $4 or less per pack. These were found to be most susceptible to these shortages. This bill seeks to reconcile these issues. The medicines suffering shortages included those that treat depression, schizophrenia, high blood pressure and many more illnesses. Certainly these patients cannot afford to have supply chain interruptions. I know; I have family members affected by some of these conditions. Supply chain interruptions are devastating to those patients. It's important that they can be sure of a secure supply of medicine.

Through COVID last year, I know that there was particularly a supply chain issue of paracetamol, for example. I don't think many people knew some of the struggles that this government had to ensure it dealt with in a pandemic coming at us at speed. It was like being in a great aircraft with both the Spanish flu and the Great Depression coming at us at speed. There were a lot of things that had to be dealt with. The minister for health, the Hon. Greg Hunt, was dealing with some of these supply chain issues himself. I have a constituent in my electorate who is the CEO of Australia's largest generic pharmaceutical company, Arrotex, Dennis Bastos. He called me up and said, 'Katie, I am having trouble with the supply chain of paracetamol as the CEO of one of the largest generic pharmaceutical distributors.' We had to work through DFAT and diplomatic engagement. Finally we actually had to take it right up to the top level, to the prime ministers of both our countries, to solve the supply chain issue with India in order to access paracetamol. Can you imagine the babies of Australia not having access to paracetamol, or the people who are dealing with fever, who are unwell at home, not having access to paracetamol? It was actually quite a critical shortage.

I know there have been many shortages over the last couple of years, and they have been dealt with because the minister for health is very effective at securing supply chains. He gets in front of the problems before they can actually cause problems to patients. We know that he is having to deal with these problems behind the scenes and on behalf of Australians, and legislation such as this will help the minister of the day, in this case Greg Hunt, to deal with supply chain issues.

In order to maintain a strong supply chain in this country, medicines with prices at or below $4 will not have their price reduced under this act. Moreover, medicines with very cheap ex manufacturer price will undergo modest price increases to ensure that manufacturers can secure strong source of supply in the global market. In light of the increased investments by the medicines industry to ensure this strong supply chain, a price reduction floor will be introduced to support the pharmaceutical industry. This is the balancing act that the minister of health needs to do to make sure that we get the best outcome for all Australians and, of course, that the taxpayer's dollar gets well invested. This amendment serves to support low-cost medicines so that these manufacturers can compete in what is a very aggressive global market as well as invest in supply chain resilience. When a PBS listed brand is protected by the price reduction floors previously mentioned, they will be under strict obligation to hold large amounts of stock in Australia. This will ensure the supply chain issues are not damaging to the Australian environment.

This bill acts to employ stockholding requirements, requiring manufacturers to hold at least four months of typical demand of stock on hand. This amendment will almost universally apply to all medicines with prices below $4 to ensure that those struggling in this country with illnesses that are affected by these medicines can rest assured that they will not have their important lifeline of medicine cut by supply issues. The amendments in this bill will ensure sustainable supply for the Australian people of the medicines they need as well as supporting the medicines industry to invest in holding greater stock of medicines most at risk of global shortages and investing in greater supply chain resilience.

Since October 2013, the coalition government has approved approximately 2,800 new or amended medicine listings on the PBS, at an overall investment by the government of $14 billion. This is something that taxpayers should be very proud of—the investment of their funds to make sure that Australians can get access to secure, reliable, highly efficient, highly impactful medicines at a very reasonable cost. The Morrison government has a demonstrated history of support for the PBS. In the 2020-21 budget, nearly $900 million was invested by this government in new and amended listings as part of the scheme. This includes for breakthrough treatments for cancer, depression, eczema, attention deficit hyperactivity disorder, pulmonary arterial hypertension, asthma, migraine and Parkinson's disease, just to name a few.

Notably, a medicinal cannabis product, cannabidiol, is now included on the PBS for use in treating Dravet syndrome, which will save more that 100 Australians and their families over $24,000 a year in costs. This is really important because these children—it is usually children who are affected by Dravet syndrome—often have very difficult lives and do not necessarily have the means to support themselves with this incredibly helpful drug, which makes such a significant difference to their lives and their quality of life.

Further examples of what's being listed on the PBS include ofatumumab. I'm giving the generic name, because it's very important that we list generic drugs. This is listed on the PBS for the treatment of relapsing-remitting multiple sclerosis. I know so many people—family members, friends and patients—who've had multiple sclerosis. It can be a devastating condition. Around 5,000 patients a year will benefit from this listing. Without subsidy, patients could pay $28,000 per year of treatment. You can imagine that someone who's affected by multiple sclerosis may, because of their chronic health condition, not have the employment to be able to afford a treatment that costs $28,000 per year. That's an enormous undertaking, so you can imagine what a relief it is for patients who have relapsing-remitting—meaning it keeps coming back and getting worse—multiple sclerosis to be able to have a treatment that will offer them support and better quality of life. It is indeed something that we should all welcome and feel very proud of.

A further drug, listed from 1 September 2021, is cariprazine—getting the names right can be quite tricky even for a doctor—which is listed for the treatment of schizophrenia. This means that 39,500 people will benefit, each being saved $1,200 per year for treatment. From 1 October 2021—I'm really going to struggle with this—brolucizumab is listed for patients with age related macular degeneration, a terrible chronic eye condition that causes blurred vision or a blind spot in the visual field. People can lose vision, and it can be quite a serious condition. With the listing, 12,800 patients will each save around $8,800 per year for treatment. These are treatments that cost hundreds or thousands of dollars per year, and they could be out of reach for so many, but instead, on the PBS, they will pay $41.30 per script, or $6.60 per script if they have a health concession.

Another drug that has been listed from 1 June 2021 is progesterone, or Oripro, to prevent women going into premature labour, saving around 14,250 women up to $300 per course of treatment. A further drug is lisdexamfetamine, the listing of which has been expanded to include patients who are diagnosed with ADHD after they turn 18 years of age. We know ADHD is a problem that affects so many people, particularly children. As they grow older, if they want to continue to take treatment, around 20,000 patients could access comparable treatment for this condition and could benefit from this new treatment option. Without PBS subsidy, patients might pay $1,200 per year for treatment.

Finally, the listing of ipilimumab will be expanded for use in combination when treating patients with unresectable malignant mesothelioma, which is a lung condition that can occur when people have had unexpected exposure to asbestos. Over 700 patients a year may benefit from this listing. Without the PBS listing, patients might pay around $130,000 per course of treatment, a huge amount of money. It's wonderful that these drugs are available for conditions that affect only a small number of Australians—but it could be any of us. Recently, a family friend picked up some tiles when he was renovating an apartment block and found, to his horror, that there was asbestos underneath these tiles. Hopefully, he hasn't had a harmful exposure, but it was a fright that he got, and obviously you never know when you may get exposed to asbestos. So it's great to know that our medical system and our health system are protecting people and supporting people to protect lives and save lives.

This bill will serve to offer low medicine prices for Australians whilst improving the supply chain that helps Australians get what they need. The Morrison government's commitment to the success of the PBS is clear, with a strong record of new medicines being listed and now this bill being brought forward so that the Australian people can continue to have faith in this government's management of medicines listed on the PBS and so that they can work well, hand in glove, with the pharmaceutical companies and Medicines Australia to ensure a balanced outcome that supports a cost-effective way of ensuring that both supply chain issues and the cost of medicines are kept in check. It is vital that every Australian retain their ability to access medicine. Any shortage is unacceptable as this country strives for a system whereby each and every one of us can access affordable and effective medicine. I commend this bill to the House.

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

There is no doubt that the COVID pandemic has affected not just Australia but also countries around the world in many ways in addition to the death and serious illness it has caused. As many people before me have spoken about in this chamber, one of the impacts has been on global supply chains and medicine supply. Australia hasn't been immune to that. But this is another example of a government that has been in office for eight years and has failed in that time to put in place plans and procedures, to think about how it would react to things like global pandemics that might affect supply chains. While it's terrific that things are being addressed now, and that this bill, the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021, has some measures that will go towards access to medicines when there has been a disruption in supply chains, it's pretty rich, I have to say, for members of the government to come in here and pat themselves on the back over what a great job they've done during this global pandemic, over how they had to get involved at the last minute to stop shortages of medicines and over how this legislation will make changes when it's reactive, not proactive, when issues with supply chains were known before the pandemic and they didn't do anything about it. Local manufacturing of medicines has needed government support and hasn't got it in the eight long years of this government.

We know that there are 263 medicines listed by the TGA that are experiencing shortages in Australia, and another 54 are anticipated. Not all of that could have been prevented had this government had an actual plan for how to deal with the consequences of the global pandemic, but some of it could have been. Shortages of medicines, including medicines for cardiovascular disease, diabetes, epilepsy, high cholesterol, severe pain and mental health conditions such as depression, bipolar disorder and schizophrenia—these are not conditions where people should be left wondering how they're going to fill their next script. These are not conditions where it's okay if you miss your medication for a little while.

I had a constituent, Ms Cameron, contact my office on behalf of her husband because he couldn't get Actemra medication to treat his giant cell arteritis. We tried our best to help. We made inquiries with local pharmacists at Peninsula Health, and they said, 'Yep, there's a global shortage of it.' Ms Cameron spent four weeks trying to get her husband his medication. It took the help of my office calling pharmacies and contacting suppliers directly before she could get a month's worth of supply, and that was only because someone hadn't turned up at the pharmacy to get their supply. It leaves you wondering what happened to that person.

How is it that Australians have to go to such great lengths to obtain medication? I have written to the minister on behalf of Ms Cameron and her husband, acknowledging the global shortages that I have spoken about. But what is the Morrison government doing to ensure the supply of Actemra increases? She can't do this every month. She is not going to be so lucky that every month somebody forgets to go or can't go and collect their script, so that she can get one for her husband. Or is it the case that the government expects her to go through that process to get that medication every month?

While the provisions in this bill are welcome, it is a shame that it's reactionary, after people have experienced the consequences of not being able to access medicines, of not being able to pay for medicines and of the global supply chain shortages—not before. It's why it's really important to have vision—vision like Labor's proposal for a reconstruction fund to support manufacturing, to diversify manufacturing and to manufacture medicines as we come out of COVID. Fifteen billion dollars in a reconstruction fund to strengthen and diversify Australian manufacturing including the manufacturing of medicines: that's the sort of policy this country needs—actually delivering an mRNA vaccine manufacturing capacity in Australia, not just talking about it. This is something the Morrison government promised long ago but is yet to deliver. That's the sort of delivery and vision, not announcement, that this country needs, and needs desperately, and that would be provided by a federal Labor government.

I want to also talk about one example that my colleague the member for Cowan talked about just before me and my colleague the member for Macarthur, who is sitting next to me, tabled a petition on recently, and that's a drug that's not yet on the PBS but that would help families with loved ones suffering from cystic fibrosis, and that's Trikafta. The member for Cowan spoke about the drug, saying because it's not listed on the PBS it costs something like $300,000 a year for people to access. She doesn't know anyone who could pay that. I certainly don't know anyone in my electorate who could pay that much money. But I know people who would sell everything that they own to get that much money, if only they could, to make the lives of their children who suffer from cystic fibrosis better. They shouldn't have to.

Rachelle from Frankston South is one of those people waiting for Trikafta to be listed, for her son. He struggles to breathe every day, and, not surprisingly, she lived in ongoing fear about COVID-19 and what would happen if he was to catch it, even with vaccinations. This is what Rachelle emailed me: 'Cystic fibrosis is an awful disease to live with. It's symptoms are often very difficult to manage. I have learnt not to expect miracles, but I certainly do still expect fairness. But now it's clear that in this latest round, following PBAC applications, we will receive neither. The miracle is right there, just out of reach, because Vertex and the government were unable to come to an agreement. My family will suffer. Other families will suffer, some may even lose the ones they love. Individuals cannot afford Trikafta on their own. We need help. But it is a cutting-edge medicine with proven effectiveness. Trikafta improves lung function, decreases exacerbations and improves weight gain for an overwhelming majority of CF patients. There is no substitute. There is nothing that can offer the same hope, the same lease on life.' She wrote to me: 'Please use your power to help make the powers that be reconsider Trikafta. There is always something that can be done, always a proposition to be made or an angle to be explored. Please step up the pressure, and hopefully your efforts will bring both parties to the negotiating table. In the meantime, CF Australians need compassionate access to Trikafta so that lives and life years can be saved while the negotiations are dragging on. I am one person,' says Rachelle, 'but there are many more like me, and we are all standing up to be counted. Please stand with us, and don't let the government give up on us by giving up on Trikafta. Yours, in help, parents of a child with CF, Rachelle and her husband.'

Today I am standing up with Rachelle and all of the other constituents who have contacted me on behalf of their loved ones, to support them and to put Rachelle's words before the parliament about what Trikafta could do if only it was affordable and accessible. I lend my support to their campaign for the government to get that negotiation done and to get it listed on the PBS.

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

NDER () (): It's a real pleasure to speak after my friend the member for Dunkley. Of course, Labor does support this bill, and we note its importance as it seeks to integrate the recently agreed medicines agreement between the Commonwealth and the pharmaceutical industry, in particular Medicines Australia and the Generic and Biosimilar Medicines Association.

I started my career as a medical student in 1972, so next year it will be half a century, which doesn't seem so long ago to me but may seem a long time ago to others.

Honourable Member:

An honourable member interjecting—

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

Unfortunately, it is. Australia's health system post the Second World War has been acknowledged as amongst the best in the world. I think there are three pillars of that. At the present time, one pillar is Medicare, initially introduced by Gough Whitlam as Medibank. Of course, it was destroyed by the Fraser Liberal-National government but reincarnated by the Hawke Labor government as Medicare. Another pillar is the PBS system, the Pharmaceutical Benefits Scheme, which was initially conceived by Ben Chifley when he was Treasurer in the Curtin wartime government and developed fully by Chifley as Prime Minister in 1949. The third pillar is of course the National Health Reform Agreement, negotiated in 2011 by Julia Gillard to provide financial support for our hospital system. Those three pillars were introduced by Labor governments, and it's a part of our DNA that we provide the best and most equitable health services to all Australians.

Unfortunately, in the last seven or eight years, there's been a gradual deterioration in the equity of our health system so that people are now finding it very difficult to afford appropriate treatments, even in terms of doctors' appointments. In outer metropolitan, rural and regional areas there's been enormous difficulty in attracting general practitioners. I've approached the present health minister on numerous occasions about this, and nothing has been done. It's leading to very inequitable care, with people not being able to access primary care and falling back on our hospital emergency departments as their primary carers. That's one issue.

The other issue is that there have been supply chain shortages for medications in Australia for a number of years, long before the pandemic, and this government has not addressed them. I'm talking about, for example, some of the common antibiotics. There was a severe shortage of the third generation cephalosporins, which are not manufactured in Australia, in 2018, to the point where, as doctors working in hospitals, we were told to restrict use of them; and common penicillin-based antibiotics like ampicillin were very difficult to access because of supply chain problems. And for a number of years there have been shortages of adrenaline for auto-injectors, which are used to treat severe anaphylaxis. This was not addressed by the government until very, very recently, and, even now, there are still shortages. So supply chain difficulties have existed for a long period of time.

The PBS system is a cornerstone, one of the pillars of our health system, and we must make sure that it's fit for purpose. This bill will partly address that issue, but it doesn't fully address the issue. It has been a major concern of mine that the ability of Australians to access the best medications, the 21st-century-type medications, has been falling behind because of the difficulties in approval for these medications in Australia with a system that has not been reviewed for some time.

To his credit, the minister did ask the Standing Committee on Health, Aged Care and Sport to undertake an inquiry into how we assess medication availability in the 21st century, and we've come up with a number of recommendations. My concern is that those recommendations will be sitting on a shelf for another six, seven or eight years if this government is re-elected. They have been very slow to respond to previous requests for improvements. I mentioned the GP access scheme. The Medicare review has led to even more difficulties in people accessing primary care. I am very worried that our recommendations for precision medicine and access to the best treatments for Australians will be left in a cupboard for far too long.

We already heard mention of Trikafta. Trikafta is a medication for cystic fibrosis which is used for people who have the most common gene mutation—the delta F508 mutation; at least one copy of that with cystic fibrosis—and it is life changing. It is absolutely remarkable. Patients who have been placed on the heart-lung transplant list because their lung function is so poor have been put on Trikafta and the improvement in their lung function has been remarkable—sometimes from as low as 15 or 16 per cent up to 40 per cent, which is a really remarkable improvement. We are now seeing patients with cystic fibrosis, with these newer treatments like Trikafta, living normal or near-normal life expectancy. When I started my training, most people with cystic fibrosis were dead by their late teens or early 20s. These are remarkable 21st century genetic treatments, and we must approve them for Australians with cystic fibrosis and other genetic disorders so that we get equitable access around Australia.

There are other medical interventions—not necessarily medications—that we have been very slow to access. There's a new one—when I say 'new', it has been used overseas for a long time—called the Omnipod, which is a treatment for type 1 diabetes. It is attached to the skin, usually of the abdomen, and acts as an automatic artificial pancreas. The settings can be changed remotely, there is no external tubing or visible pump involved, and it's all in a small pod attached to the abdomen. It's a remarkable treatment that's been used overseas for a number of years. It's really good for adolescents, and anyone who has a child with type 1 diabetes knows that adolescence can be a real difficult time because kids get very self-conscious about having attached tubing when doing things like playing sport or going out with friends. This is a terrific advancement for those adolescent kids with type 1 diabetes. For very young children with type 1 diabetes it's great because it can be set remotely, it doesn't require skin pricks to measure blood glucose and it doesn't require external tubing that can be tangled in toys and things like that. So it's a really great treatment, yet Australia has been very slow to approve it. We must do better.

During the pandemic, we have had a pretty good response from the TGA, I think. They have been pretty remarkable in how hard they have worked to approve vaccines and new treatments, but we still have a number of difficulties in approval for a range of 21st century medicines. I think that it is time that the government really had a vision statement about where they see our PBS heading in the next 20 or 30 years. I recommend the standing committee's report to the minister again. I really encourage him to let us know how the government is going to respond to our recommendations.

We as a parliament have a duty of care to Australians. Our bipartisan report, involving members of the government and members of the opposition, pretty clearly outlines a vision for the PBS system and approval process in the future. We've made a total of 31 different recommendations, a couple of which are really important to me. The one talking about the establishment of a centre for precision medicine is a really important one. I would like to see it expanded even further to have a properly funded institute for precision medicine that is Australia-wide. The other one that is very important to me is the establishment of a national newborn screening program with a regular review process that is instituted all around Australia so that everyone gets equitable access to the best possible treatments.

As an example, there is a condition, spinal muscular atrophy, that many people have heard me speak about. It's a genetic condition in which a child is born normal but whose muscles gradually waste away after birth. Those children previously have died by the time they were two or three years of age because of muscle weakness and respiratory failure. There are new genetic treatments available for this that we feel are likely to be curative, and we have certainly seen some very positive results. That condition is only screened for in a number of Australian states, not in all states. Some children are being missed, and the longer the diagnosis is missed the more damage occurs. It is very important that the medication is made available as soon as possible after birth. It's also very important that children who have a milder form of spinal muscular atrophy who survive into adulthood are given access to the genetic treatments through the PBS. At the present time it's only available for people 18 years and under. It should be extended to those over 18 to try and prolong their lives.

In summary, Labor strongly believes in an equitable health system for all Australians. The pillars of our health system, including the PBS, are always supported by Labor. We commend the bill to the House, and I hope that, as I said, the government can go even further and provide a vision for their view of the PBS system for the next 20 years.

Craig Kelly (Hughes, Independent) Share this | Link to this | Hansard source

I rise this evening to speak on the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021. It was a pleasure to listen to the member for Macarthur, who spoke before me, outline some of the significant breakthroughs that are coming down the track that can improve the quality of Australians lives, but we must remember that to list drugs on the Pharmaceutical Benefits Scheme, to make them available to Australians at an affordable cost, costs money. We have first to create wealth out in the community.

There was a period in the time that I've been a parliamentarian when this parliament, in the three years from 2010 to 2013, then under a Labor government, decided that, because of the budgetary situation, the listing of some drugs on the PBS had to be delayed. The member for Ryan was correct when he spoke about that. However, there is no point in continuing to list drugs on the PBS if it's all done by running up our debt. Back when the listing of new drugs on the PBS was suspended the debt was something around the $100 billion mark. Today, national debt stands at something like $1,000 billion—a trillion dollars' worth of debt. This debt is going to greatly compromise this parliament's ability to continue to list on the PBS new life-saving drugs and drugs that will improve the quality of life of many Australians.

I have a second reading amendment that I am proposing, which has six separate points. I will quickly go through some of those. The first one is:

"whilst" … "not declining to give the bill a second reading, the House notes:

(1) that the price of the drug Ivermectin in Australia under the Pharmaceutical Benefits Scheme (PBS) is significantly higher than reported elsewhere in the world;

I had a quick look on the PBS schedule, and it has the price for a pack of four three-milligram tablets of ivermectin at the maximum safety net price of $41.30. Yet anyone who looks on the internet can see that same drug available out of India costing something like 20c Australian per tablet, so a pack of four, which you can buy online from India, would be less than a dollar, yet it is $41 even under the Pharmaceutical Benefits Scheme. Something is going very wrong if a drug that costs less than a dollar to make is being sold to Australians, even under the Pharmaceutical Benefits Scheme, for $41.30.

The second point in the amendment that I am moving is:

(2) that on 10 September 2021, the TGA placed new restrictions on prescribing Ivermectin through the PBS for COVID-19, denying sick Australians access to a medicine that many medical experts believe could save lives, and this denial of Australians' access to a medicine through their doctor was described by experts—

including no less an authority than Emeritus Professor Robert Clancy—

as 'a sad and shameful day for Australian medicine';

I'll quote from the article. Again, these are not my words; these are the words of Emeritus Professor Robert Clancy, which he published an article in Quadrant on 13 September. He said:

September 10, 2021, was a black day, the day a group of faceless bureaucrats known as the "Advisory Committee for Medicines Scheduling", through its effector arm, the Therapeutic Goods Administration (TGA), compromised medical practise and the health of their fellow Australians. The TGA used its regulatory muscle to prevent doctors at the COVID-19 pandemic's coalface from prescribing ivermectin (IVM), the one therapy available that is safe, cheap and which reduces mortality in the order of 60 per cent.

These are not Craig Kelly's words; these are the words of Emeritus Professor Robert Clancy. I will continue to read from his article:

This poorly conceived action threatens the high standards of medical practise we have achieved in Australia, and the credibility of the administrative structure within which medicine operates.

The immediate consequence of the TGA Notice means patients contracting COVID-19 are left to hear, "Sorry, no treatment for COVID-19 is legally available. Just go to hospital when you get very sick." In the longer term it means that bureaucrats can change the way medicine is practised for whatever reason without review by, or discussion with, the medical community. It is important for Australians to consider two issues that follow the TGA's decision: first, it adds risk to those exposed to COVID-19, putting additional pressures on health-care facilities; second, it drives a wedge into the fault lines that have appeared in medical practise during the course of the COVID-19 saga.

Looking at the first issue, the decision by the TGA to prevent general practitioners from prescribing IVM to manage COVID-19, the Notice is flawed and misleading, although giving clues to its political motivation.

Again, I am quoting directly from Emeritus Professor Robert Clancy. He writes:

The evidence that IVM is safe and effective in both preventing and treating early (pre-hospital) COVID-19 is overwhelming, as has been  laid out in four Quadrant articles published through 2021. Despite this evidence, every artifice has been used to quash IVM's use and to do so in unprecedented fashion. The causes for the suppression include political agendas, pressures from pharmaceutical companies, ideology and breakdown in medical communication. This latest blow by the TGA follows its previous form in shutting down use of hydroxychloroquine, another safe, effective and cheap COVID-19 therapy. Every experienced doctor prescribes drugs for 'off-label' indications. It is anathema and dangerous that the doctor-patient relationship can now be over-ridden by government agendas.

Again, these are not my words but the words of one of the most senior, respected and highly qualified immunologists in this country. He concluded:

The authoritarian and poorly conceived interference by the TGA in the effective running of clinical medicine, and its broader implications, is a further splintering event. This is a time when everyone needs to be on message to counter a devastating pandemic. The use of blunt legal tools to threaten and bully doctors with de-registration, legal action for "advertising" and even with jail terms for striving for the transparency and common sense that has served medicine so well compromises the rules of science and the doctor-patient relationship upon which our profession is built. The answer is transparency and communication around agreed goals based on science. We should again involve all levels of health care and the public we serve. The decision-making process should include clinicians familiar with the problem to ensure the pragmatic and common-sense approach needed to get us through this pandemic with minimum damage.

This is his final paragraph:

Rather than create the chaos and loss of respect for an important institution that will follow continued enforcement of the current Notice, the TGA should initiate a working party that includes frontline doctors to establish an agreed treatment protocol that includes dosage, with monitoring of the outcomes. We live in dangerous times that call for new ideas able to address a real world crisis that is out of control and will only get worse without a different way of thinking.

They are the words of Emeritus Professor Clancy, written in an article on 13 September.

The third point in the amendment that I would like to move is that the recently published Australian data evidence is that ivermectin prescribed under the PBS in Australia prior to the TGA's ban combined as part of a triple therapy including zinc and doxycycline has been highly successful in reducing hospitalisations and deaths. We actually have some data to show how effective this has been; this is not just some theoretical argument or theoretical conclusion put forward by Emeritus Professor Clancy. There is a paper that has been published with the lead authors Thomas Borody and Professor Clancy. In this study, they took 600 Australian residents with positive PCR symptomatic COVID and treated them with ivermectin, doxycycline and zinc for 10 days. The treatment period was from June to September 2021. It involved two states, New South Wales and Victoria, and over 30 frontline doctors. The result of those studies were that only two people visited hospital, for 24 hours, and went home. A total of five people in that study were admitted to hospital, 0.83 per cent, and there were no deaths.

In an equivalent control group, so if we took another 600 Australians with similar characteristics who weren't in general society and weren't given Dr Borody's triple therapy, what were the results? On average, 70 were admitted to hospital: 11.5 per cent. So we have those who took Dr Borody's triple therapy, with 0.83 per cent admitted to hospital; and those who didn't, with 11.5 per cent. The number of deaths in that equivalent group: six. In Dr Borody's group: 0.

When we have such results in an Australian based study, how is it possible that we are denying Australians access to these treatments? This is what the TGA have done. I do not know whether this drug is effective, but I do know that Australians should not be denied access to this treatment when we have published studies showing such results. Surely when we have people dying every day of COVID we have the right to try in this country. Surely doctors must have the right to practice medicine. Those rights are being taken away by a bad decision of the TGA that is criticised by some of our most senior immunologists in this country.

As I'm short of time on the clock, I will quickly also note that the TGA said there had been a threefold to fourfold increase in dispensing ivermectin prescriptions in recent months. They were concerned about the safety of this. We can go to the TGA's DAEN database and see whether this led to more reports of adverse events. We can see throughout the entire length of the pandemic, from 1 January 2020 to 14 November, the latest data of 2021, that there were only two cases of adverse events reported by people taking ivermectin as a single suspect medicine, and one of those took it not through the prescription. In comparison, the number of reports from the COVID vaccines on the same database for the same period is 80,669 cases.

I move:

That all words after "whilst" be omitted with a view to substituting the following words:

"not declining to give the bill a second reading, the House notes:

(1) that the price of the drug Ivermectin in Australia under the Pharmaceutical Benefits Scheme (PBS) is significantly higher than reported elsewhere in the world;

(2) that on 10 September 2021, the TGA placed new restrictions on prescribing Ivermectin through the PBS for COVID-19, denying sick Australians access to a medicine that many medical experts believe could save lives, and this denial of Australians' access to a medicine through their doctor was described by experts as 'a sad and shameful day for Australian medicine';

(3) recently published Australian data provides evidence that Ivermectin prescribed under the PBS in Australia (prior to the TGA's ban) combined as part of a 'triple therapy' including Zinc and Doxycycline (also prescribed under the PBS) has been highly successful in reducing hospitalisations and death;

(4) that the TGA noted on 10 September 2021 there had been a 3 to 4-fold increase in dispensing of Ivermectin prescriptions through the PBS in recent months, however the TGA Database of Adverse Events records no increase in adverse events;

(5) that a reason for denying Australians' access to Ivermectin through their doctor and the PBS to treat COVID-19 included the reason of 'national and local shortages for those who need the medicine for scabies and parasite infections', however medical regulators failed to take steps to overcome this shortage; and

(6) that this denial of Australians' access to this medicine through their doctor and the policies of other nations to adopt widespread use of Ivermectin to tackle COVID-19, have created a black-market for the drug undermining Australia's PBS".

I commend this amendment to the House.

Llew O'Brien (Wide Bay, National Party) Share this | Link to this | Hansard source

( ) : Is there a seconder?

George Christensen (Dawson, National Party) Share this | Link to this | Hansard source

I second the amendment and reserve my right to speak.

Debate adjourned.