PBS wait times a more urgent issue than Donald Trump's potential pharmaceutical tariffs, peak medicines body warns
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Excessive wait times for medicines to be listed on the Pharmaceutical Benefits Scheme (PBS) are a much greater threat to the sector than US President Donald Trump's far-reaching tariffs, according to the peak industry body, which has warned people could die waiting for treatment.
The Albanese government is frantically working to shield Australia from Donald Trump's ever-expanding tariffs, with the US president now flagging a possible 250 per cent tariff on pharmaceuticals, one of Australia's largest export products to the US.
"We'll be putting a, initially, small tariff on pharmaceuticals. But in one year … it's going to go to 150 per cent and then it's going to go to 250 per cent because we want pharmaceuticals made in our country," Mr Trump told CNBC on Wednesday local time.
But Medicines Australia CEO Liz de Somer said a more pressing concern was the process behind listing new medicines on the PBS, with a median wait time of 22 months for a new medicine to land on the scheme once it is approved by the Therapeutic Goods Administration (TGA).
"Patients will die waiting for new medicines to be listed," she said.
"And this will have a far greater effect on the Australian system than anything else."
When drugs are placed on the PBS, patients are able to receive important and sometimes lifesaving medicines at a small portion of the cost — currently just over $30. The rest of the cost is covered by the federal government.
But patients, advocacy groups and pharmaceutical companies argue the process leading up to the PBS listing is overly complex, takes too long and involves excessive red tape.
The first complete review of the system in 30 years was handed to the federal government last year, making a raft of recommendations to streamline processes so people could access medicines earlier.
The recommendations included expanding access to medicines already subsidised for common cancers to other cancers, when that is backed by evidence.
The review also concluded that if pharmaceutical companies applied to have their medications approved by the TGA and placed on the PBS at the same time, 90 per cent of promising new medicines could be listed within six months of TGA registration.
Federal Health Minister Mark Butler heralded the Health Technology Assessment (HTA) review as "visionary" but has yet to formally respond to its findings, instead setting up an advisory group to help guide the government's next steps.
Rare Cancers Australia CEO Christine Cockburn said urgent action was required, with many people unable to afford lifesaving medication that can cost hundreds of thousands of dollars.
"They sometimes access superannuation, which of course that is not what superannuation is for, or they remortgage their houses.
"Crowdfunding is not uncommon in cancer treatment spaces, which of course comes with a terrible loss of dignity. It's a terrible thing to have to do, and there are people as well who just have to go without because they can't do any of those things."
PBS 'egregious and discriminatory': US pharmaceutical companies
The time it takes to list medications on the PBS is a long-held gripe of US pharmaceutical companies.
They also argue the scheme's pricing policies undervalue American innovation and threaten billions of dollars in lost sales.
In March, American medical giants pressed Donald Trump to target Australia with punitive tariffs, labelling the PBS as one of the "egregious and discriminatory" programs that undermines US exports.
Labor has already categorically ruled out touching the PBS in any trade negotiations, and a raft of frontbenchers have consistently stressed the Trump administration could not exert any direct influence on the scheme.
But the government remains concerned that frustrations over the PBS could see the Trump administration retaliate by hitting Australian pharmaceutical exports.
Last year, Australia exported $2.2 billion in pharmaceutical products to the US — about 40 per cent of Australia's pharmaceutical exports — according to the UN's Comtrade database.
Ms de Somer said the government could better negotiate with the US, while still protecting the PBS, if it followed recommendations from the review.
"If the government committed to implement the reforms of the PBS that they have already identified need to happen, it would go some way to assuage the concerns raised by Donald Trump and the US pharmaceutical industry," she said.
"Partly, it is about the time it takes for patients to get access to new medicines, and partly it is about valuing innovation and giving the right value to things that are new and transformative and change people's lives."
"I don't think there's anybody involved in this process that doesn't want to see this happen faster," Professor Wilson said.
"One of the challenges that we've had in the past is not that things haven't changed, but they've changed in a piecemeal fashion. They've changed little bits here and not there and the concern has been the extent to which those changes have actually improved the system, or just made it more complicated."
However, Shadow Health Minister Anne Ruston accused the government of dragging its feet in its response to the review.
"We're sitting here now nearly 12 months after the review has been delivered to government and we have absolutely nothing more from the government," she said.
"It's completely unacceptable because Australians are missing out on a much speedier process to get them access to life-saving and life-changing drugs. And that's just not good enough."
Mr Butler said the implementation advisory group's final report was due early next year, and would help inform future government decisions on reform.
"The Albanese government is continuing to make medicines available to Australian patients faster and cheaper," he said.
"We know patients want faster access to cutting-edge medicine and treatments.
"That's why our government is working through the recommendations of the HTA review, so Australians can get faster access to the best medicines and therapies, at a cost that patients and the community can afford."
By national health reporter Stephanie Dalzell
The Albanese government is frantically working to shield Australia from Donald Trump's ever-expanding tariffs, with the US president now flagging a possible 250 per cent tariff on pharmaceuticals, one of Australia's largest export products to the US.
"We'll be putting a, initially, small tariff on pharmaceuticals. But in one year … it's going to go to 150 per cent and then it's going to go to 250 per cent because we want pharmaceuticals made in our country," Mr Trump told CNBC on Wednesday local time.
But Medicines Australia CEO Liz de Somer said a more pressing concern was the process behind listing new medicines on the PBS, with a median wait time of 22 months for a new medicine to land on the scheme once it is approved by the Therapeutic Goods Administration (TGA).
It takes a median time of 22 months for a medicine to appear on the Pharmaceutical Benefits Scheme after it has been approved by the regulator. (Pixabay)
"Patients will die waiting for new medicines to be listed," she said.
"And this will have a far greater effect on the Australian system than anything else."
When drugs are placed on the PBS, patients are able to receive important and sometimes lifesaving medicines at a small portion of the cost — currently just over $30. The rest of the cost is covered by the federal government.
But patients, advocacy groups and pharmaceutical companies argue the process leading up to the PBS listing is overly complex, takes too long and involves excessive red tape.
The first complete review of the system in 30 years was handed to the federal government last year, making a raft of recommendations to streamline processes so people could access medicines earlier.
The recommendations included expanding access to medicines already subsidised for common cancers to other cancers, when that is backed by evidence.
CEO of Medicines Australia, Liz de Somer, said patients could die waiting for drugs to be added to the PBS. (Supplied: UNSW Media
The review also concluded that if pharmaceutical companies applied to have their medications approved by the TGA and placed on the PBS at the same time, 90 per cent of promising new medicines could be listed within six months of TGA registration.
Federal Health Minister Mark Butler heralded the Health Technology Assessment (HTA) review as "visionary" but has yet to formally respond to its findings, instead setting up an advisory group to help guide the government's next steps.
"They sometimes access superannuation, which of course that is not what superannuation is for, or they remortgage their houses.
"Crowdfunding is not uncommon in cancer treatment spaces, which of course comes with a terrible loss of dignity. It's a terrible thing to have to do, and there are people as well who just have to go without because they can't do any of those things."
PBS 'egregious and discriminatory': US pharmaceutical companies
The time it takes to list medications on the PBS is a long-held gripe of US pharmaceutical companies.
In March, American medical giants pressed Donald Trump to target Australia with punitive tariffs, labelling the PBS as one of the "egregious and discriminatory" programs that undermines US exports.
Health Minister Mark Butler said the government was working through the recommendations of the HTA review. (ABC News: Ian Cutmore)
Labor has already categorically ruled out touching the PBS in any trade negotiations, and a raft of frontbenchers have consistently stressed the Trump administration could not exert any direct influence on the scheme.
But the government remains concerned that frustrations over the PBS could see the Trump administration retaliate by hitting Australian pharmaceutical exports.
Last year, Australia exported $2.2 billion in pharmaceutical products to the US — about 40 per cent of Australia's pharmaceutical exports — according to the UN's Comtrade database.
"If the government committed to implement the reforms of the PBS that they have already identified need to happen, it would go some way to assuage the concerns raised by Donald Trump and the US pharmaceutical industry," she said.
"Partly, it is about the time it takes for patients to get access to new medicines, and partly it is about valuing innovation and giving the right value to things that are new and transformative and change people's lives."
Reform won't be simple: Former PBAC chair
Former chair of the Pharmaceutical Benefits Advisory Committee (PBAC), which recommends medicines for the PBS, and chair of the review's implementation advisory group, Andrew Wilson, said the complexities of the system made it difficult to reform."I don't think there's anybody involved in this process that doesn't want to see this happen faster," Professor Wilson said.
"One of the challenges that we've had in the past is not that things haven't changed, but they've changed in a piecemeal fashion. They've changed little bits here and not there and the concern has been the extent to which those changes have actually improved the system, or just made it more complicated."
"We're sitting here now nearly 12 months after the review has been delivered to government and we have absolutely nothing more from the government," she said.
"It's completely unacceptable because Australians are missing out on a much speedier process to get them access to life-saving and life-changing drugs. And that's just not good enough."
Mr Butler said the implementation advisory group's final report was due early next year, and would help inform future government decisions on reform.
"The Albanese government is continuing to make medicines available to Australian patients faster and cheaper," he said.
"We know patients want faster access to cutting-edge medicine and treatments.
"That's why our government is working through the recommendations of the HTA review, so Australians can get faster access to the best medicines and therapies, at a cost that patients and the community can afford."
By national health reporter Stephanie Dalzell
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. If he can put the tariff up to 250% like he claims he is going to do we will be done for. The elderly on pensions will not be able to afford medication so that will get rid of us quickly.
