Adequate and sustainable funding a must, say AusBiotech, Medicines Australia and MTAA

As the 2024–25 Federal Budget looms, the Research & Development Taskforce, comprising AusBiotech, Medicines Australia, and the Medical Technology Association of Australia (MTAA), is urging the Australian Government to allocate “adequate and sustainable funding” to the National One Stop Shop for clinical trials.

At MTAA’s MedTech ’23 Annual Conference, the Minister for Health and Aged Care, Mark Butler MP, unveiled the appointment of Emeritus Professor Ian Chubb, Chair of the Inter-Governmental Policy Reform Group (IGPRG) for health and medical research, to lead the implementation of the National One Stop Shop.

Highlighting the challenges in the current clinical trials landscape, Minister Butler expressed concerns about fragmentation and inefficiency, especially in multi-site, multi-jurisdiction clinical trials.

“This affects our ability to get the maximum benefit from research that is delayed or simply doesn’t commence because it’s just too hard,” he explained. “This, in turn, affects our ability to attract and develop capacity, leading to real talent shortages across the workforce.”

Clinical trials provide patients with access to innovative treatments at no cost, reducing the burden on the public healthcare system. In 2019 alone, 95,000 patients participated in clinical trials, underscoring the significant impact on healthcare affordability.

In their pre-budget submission, the Research & Development Taskforce stressed “Failure to allocate funds to the National One Stop Shop poses significant risks to both patients and the broader healthcare landscape. Without adequate funding for the National One Stop Shop, Australia’s clinical trial landscape will fragment further as each jurisdiction continues to develop their own systems and processes that are not interoperable. Australian patients will experience prolonged wait times or, worse, miss out on the opportunity to access cutting-edge medical therapies.”

Echoing this sentiment, Pfizer said in its pre-budget submission, “While government has committed to implementing this policy it has not yet been funded. It is crucial that it is funded in this budget to avoid losing momentum and to secure Australia’s future as a destination of choice for international clinical trials that can put patients at the forefront of potential new treatments.”

The Research & Development Taskforce further noted “Additionally, the lack of sustainable funding for the National One Stop Shop may lead to a decline in clinical trial activity. Biopharmaceutical and medical technology companies may prioritise conducting trials in countries with more efficient and streamlined systems.”

Drawing attention to global initiatives, the submission highlighted the European Union’s Clinical Trials Information System (CTIS), launched in 2022. The CTIS harmonises clinical trial processes across EU Member States, making it easier for sponsors to conduct trials.

The Taskforce emphasised the need for Australia to keep pace with the changing global landscape, advocating for appropriate funding in the 2024–25 Federal Budget to implement and sustain a single, efficient, and streamlined clinical trial system nationwide.

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