Sustainable funding sought for National One Stop Shop for clinical trials


A 2024-25 Pre-Budget submission urging for sustainable funding for the Government's National One Stop Shop for clinical trials has been submitted by the Research and Development Taskforce, a multi-sector collaboration between AusBiotech, Medicines Australia and the MTAA.

The group has urged the Government to provide appropriate and sustainable funding to the National One Stop Shop for clinical trials in the 2024–25 Federal Budget, so that the country remains a globally competitive R&D destination, and for Australian patients to have access to the latest medical therapies.

The National One Stop Shop (NOSS) for clinical trials is a digital platform that will provide a coordinated system of approval and reporting processes for human research, including clinical trials in Australia. Australia is a good destination for clinical trials, with excellent healthcare facilities, world-class researchers, a diverse population, and strong legal frameworks with robust IP protections. However, the complex regulatory environment for trials in Australia can act as a barrier for companies looking for efficient and cost-effective locations.

Beyond a digital platform, the NOSS is an opportunity within the broader clinical trial and medical research reform underway, that will provide a single, harmonised, end-to-end process across the different jurisdictions.

The RDTF said in its pre-Budget submission that failure to allocate funds to the NOSS poses significant risks to both patients and the broader healthcare landscape, and noted RDTF’s commitment to working collaboratively with the Government to support its development and implementation.

“Investing in the NOSS is not just a commitment to the health and well-being of Australians but also an economic imperative, fostering innovation, creating jobs, and positioning Australia as a global leader in research and development.

“Without adequate funding for the NOSS, 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.

“Additionally, the lack of sustainable funding for the NOSS 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.”

The pre-Budget submission also noted that in 2022, the EU launched their own ‘One Stop Shop’, the Clinical Trials Information System (CTIS). The CTIS harmonises clinical trial processes between European Union Member States, European Economic Area countries and the European Commission, making it easier for sponsors to conduct trials.

“If Australia is to keep pace with the changing global landscape, we too, need a single, efficient, and streamlined clinical trial systems across the country.”

AusBiotech has supported the concepts of a National One Stop Shop since first mooted more than two years ago, through national speaking opportunities, formal submissions, and through its ongoing discussions with Ministers and departmental staff.

AusBiotech is dedicated to promoting Australia globally as a key destination to conduct clinical trials, and a well-designed National One Stop Shop will be instrumental in supporting this mission. Clinical trials play a pivotal role in the economy of the future; already supporting more than 8,000 innovative Australian jobs, in 2019 clinical trials contributed more than $1.4 billion to the Australian economy – demonstrating its value in supporting the country’s transition from a post-mining boom.

Read the pre-Budget submission here.