The valid point about Australian medicines that pharma giants made to Trump

Health Minister Mark Butler concedes it’s taking too long for Australians to get new medicines, while US pharmaceutical giants complain to the Trump administration about lengthy delays, risking retaliatory action.

The federal government is slowly moving on a review of the system, but Australia’s peak medicines industry group also says changes to the Pharmaceutical Benefits Scheme (PBS) are overdue, claiming it takes an average 466 days for new drugs to become subsidised after being approved for use. In other countries, it says, this process can be done in 90 days.

Health Minister Mark Butler agrees it is taking too long for the Pharmaceutical Benefits Advisory Committee to assess drugs. The Coalition says he’s taken too long to act.Credit: Louie Douvis

“It takes too long,” said Medicines Australia chief executive Liz de Somer. “Both sides of parliament recognise it. There are 50 recommendations focused on speeding up that time, but also looking at efficiencies and better ways of doing it, and they need to be implemented.”

Coalition health spokeswoman Anne Ruston blamed the Albanese government for failing to act on its promised review of PBS processes, leaving Australians waiting for affordable access to new medicines as both parties compete over health policy ahead of the federal election.

The PBS was drawn into a political dispute with the United States this week, after the major US drug company lobby group argued long approval processes and tough price negotiations in Australia amounted to “non-tariff barriers” to trade, raising the possibility of retaliatory action as Trump considers his next round of tariffs.

The Albanese government was quick to assert the PBS was off the table in any negotiations with the Trump administration, as it spruiked its $690 million promise to make medicine co-payments $6.60 cheaper. However, Butler conceded one of the companies’ points: it is taking too long for the Pharmaceutical Benefits Advisory Committee (PBAC) to assess drugs.

“The gap between being approved by the Therapeutic Goods Administration, and actually being available at PBS prices for patients, needs to be shorter,” he said.

Australians can’t access subsidised medicines until they pass PBS processes, meaning some people must pay several thousands of dollars for treatments on the private market while waiting. When drugs are approved under the PBS, they cost a maximum $31.60.

Butler said new treatments still needed to be assessed for efficacy, but he wanted faster access to innovative medicines that “frankly, we wouldn’t have imagined 10 or 20 years ago”. “I want to see them under the PBS as quickly as possible, so you don’t have to pay [that sort] of money.”

Butler commissioned a Health Technology Assessment (HTA) review of these processes in 2022. In May 2024, it gave him 50 recommendations to speed up approvals and improve reimbursement pathways.

Ruston said Butler had taken too long to action them. “The Albanese government has failed to follow through on implementing the recommendations of the long overdue HTA review,” she said.

“The government must protect Australians’ access to affordable medicines through the PBS. This should include making sure that Australian patients are getting earlier access to potentially life-saving new medicines and treatments by responding to the recommendations of the HTA review as promised.”

Butler said the review had made wide-ranging recommendations, with differing views among patients and industry about which were priorities. He said an implementation group headed by former PBAC chair Andrew Wilson was advising that process.

De Somer, who represents the industry on that group, said the system had not kept pace with new technologies.

“A new therapy might be a combination of a drug, device, blood product and service,” she said, rather than just a drug on its own. “[The system is] not set up to review that properly, and therefore struggles to get a process that is meaningful and timely.”

There were also flaws in PBAC’s method for assessing cost-effectiveness because a new medicine cannot be more expensive than its lowest-priced competitor unless it is proven to be significantly safer or better.

De Somer said this did not align with the incremental nature of innovation. “For example, [if] a patient is taking an injection every day, and it changes to a tablet, you know intrinsically that is better for the patient. But you can’t value that.”

This is one reason why newer contraceptive pills weren’t added to the PBS for decades, until this month, despite having fewer side effects and smaller doses.

Newer medicines must also compete with old versions that have become extremely cheap over time, costing as little as $1 a packet.

This leads to long delays, as drug companies and the government go back and forth before landing sufficient evidence. “It takes one to three years, just to have that argument,” de Somer said.

“The people who suffer from that are patients who are waiting.”

She also supports a “bridging fund”, similar to Britain’s, to accelerate access to very new medicines while more detailed negotiations take place.

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