Evaluating Australia’s Medicine Approval Timeline Compared to the US

Australia’s approach to drug approval has recently come under scrutiny, with critics from the United States asserting that the country’s process is excessively slow when it comes to approving new medicines. This debate centers around the balance Australia maintains between rapid access and ensuring safety and efficacy. The Therapeutic Goods Administration (TGA) responsible for approving medicines in Australia, aims to provide thorough assessments, considering safety, effectiveness, and cost-effectiveness, which often extends the approval timeline.

The TGA generally takes around 240 to 260 working days—approximately a year—to evaluate new medicine applications. This duration is notably longer than the US Food and Drug Administration (FDA), which typically completes its review in 180 to 300 days, especially during urgent health crises. For instance, during the COVID-19 pandemic, Australia approved the first COVID treatment within just two weeks of submission, exemplifying that expedited approval is possible when deemed necessary.

Drug development, regardless of approval timelines, is a lengthy and costly process. It usually takes about 15 years from the initial discovery to market approval and costs over A$3.5 billion. High failure rates also characterize this pipeline, with over 90% of candidate drugs failing to reach market approval.

In Australia, the approval process involves multiple stages: discovery, laboratory testing, animal testing, formulation, and finally, human clinical trials. These trials are divided into three phases to evaluate safety, efficacy, and comparative effectiveness against existing treatments. Once completed, companies submit their findings to the TGA for approval.

Approval timelines in Australia are impacted by several factors, such as the small market size—roughly 27 million people—which makes Australia a lower priority for some pharmaceutical companies compared to larger markets like China, India, or Europe. Additional safety data requirements and new information from overseas approvals can also delay the process.

Getting drugs onto the Pharmaceutical Benefits Scheme (PBS), which subsidizes medicine costs, adds further time. The process involves rigorous review by the Pharmaceutical Benefits Advisory Committee (PBAC), which meets only a few times per year. On average, it takes about 32 months from application to PBS listing, with an additional five months or more for final approval once recommended. These measures ensure responsible expenditure, given the scheme's annual cost of approximately $17.7 billion.

Critics from the US, including lobby groups, suggest reforming Australia’s approval procedures to speed up access to medicines. However, maintaining a rigorous approval process is vital to safeguarding public health. Australia’s TGA is recognized globally for its robust standards, and the PBS is considered a model scheme.

In sum, while Australia’s approval timeline may seem longer compared to the US, it reflects a careful balance between safety, efficacy, and cost. Critics should consider these factors before calling for significant changes, which could compromise the safety and quality of medicines available to Australians.