Growing Concerns Over Delays in Medicine Access
The issue of excessive wait times for medicines to be listed on the Pharmaceutical Benefits Scheme (PBS) is causing significant concern within the healthcare sector. Industry leaders argue that these delays pose a greater threat than the potential tariffs introduced by the previous US administration. The delay in accessing new treatments can have life-threatening consequences for patients, according to Medicines Australia CEO Liz de Somer.
The Albanese government has been actively working to protect Australia from the impact of US trade policies, particularly as former US President Donald Trump threatened to impose steep tariffs on pharmaceutical exports. These tariffs could reach as high as 250 per cent, affecting one of Australia’s largest export sectors. Health Minister Mark Butler expressed concerns about the potential implications of such tariffs and emphasized the need for continued free trade agreements.
However, de Somer highlighted that the more pressing issue lies in the lengthy process of listing new medicines on the PBS. The median wait time for a new medicine to be added to the scheme after approval by the Therapeutic Goods Administration (TGA) is 22 months. This delay can mean that patients are unable to access potentially lifesaving treatments in a timely manner.
When drugs are listed on the PBS, patients benefit from significantly reduced costs, with out-of-pocket expenses currently just over $30. However, the process leading up to this listing is often criticized for being overly complex and slow. Advocacy groups, patients, and pharmaceutical companies all point to the need for a more efficient system that reduces bureaucratic hurdles.
A comprehensive review of the PBS system was conducted last year, marking the first major assessment in 30 years. The review made several recommendations aimed at streamlining the process, including expanding access to subsidised medicines for various types of cancer when supported by evidence. It also suggested that if pharmaceutical companies applied for TGA approval and PBS listing simultaneously, 90 per cent of promising new medicines could be available within six months of TGA registration.
Health Minister Mark Butler praised the review as “visionary” but has not yet provided a formal response. Instead, an advisory group has been established to guide future steps. Christine Cockburn, CEO of Rare Cancers Australia, stressed the urgency of addressing these issues, as many patients face financial hardship due to the high cost of treatment. Some resort to using their superannuation or remortgaging their homes, while others rely on crowdfunding, which can be emotionally taxing.
International Criticism and Trade Concerns
The long wait times for PBS listings have been a longstanding issue for US pharmaceutical companies, who argue that the scheme’s pricing policies undervalue American innovation. In March, major US pharmaceutical firms urged the Trump administration to target Australia with punitive tariffs, describing the PBS as one of the “egregious and discriminatory” programs undermining US exports.
Australia exported $2.2 billion in pharmaceutical products to the US in 2022, accounting for about 40 per cent of its total pharmaceutical exports. Despite this, the Labor government has ruled out any changes to the PBS in trade negotiations. Frontbenchers have consistently stated that the Trump administration cannot directly influence the scheme.
Nonetheless, the government remains cautious about potential retaliatory actions from the US over PBS-related frustrations. Mr. Butler emphasized that the PBS is not up for negotiation under the current government, but industry leaders suggest that implementing the review’s recommendations could help ease tensions.
Challenges in Reforming the System
Reforming the PBS system is no simple task, according to Andrew Wilson, former chair of the Pharmaceutical Benefits Advisory Committee (PBAC). He noted that past reforms have often been implemented in a piecemeal fashion, sometimes adding complexity rather than improving efficiency. “I don’t think there’s anybody involved in this process that doesn’t want to see this happen faster,” he said.
Shadow Health Minister Anne Ruston criticized the government for its slow response to the review, stating that nearly a year has passed without meaningful action. She argued that Australians are missing out on faster access to life-saving drugs, which is unacceptable.
Mr. Butler confirmed that the implementation advisory group’s final report is expected early next year, which will inform future decisions on reform. He reiterated the government’s commitment to making medicines more accessible and affordable for Australian patients. “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.”