Australia's life sciences sector is pressing the federal Government to increase funding for the Therapeutic Goods Administration, as the regulator faces a growing workload that includes an expanding medicinal cannabis industry.
In a letter addressed to senior ministers and copied to TGA head John Skerritt, industry representatives called on the Government to "retain and empower Australia's world-leading therapeutics regulator by addressing the outdated funding model that it is operating within."
The letter acknowledged the Government's commitment to programs including the A$15 billion National Reconstruction Fund, the Trailblazer Universities Program for regional research and development, and the creation of an Australian Centre for Disease Control — but argued these initiatives were difficult to reconcile with the absence of sustainable federal funding for the TGA.
Signatories contended that the regulator's responsibilities have expanded considerably over the years to encompass a significant volume of 'public health activities' that go well beyond the evaluation, assessment, and monitoring of medicines and medical devices, and that the funding model has not kept up with this shift.
"The TGA is now involved in the management of medicine shortages, providing education to consumer and healthcare professionals, regulation of cannabis products, and management of nicotine vaping products. We fully support this essential public health work. The Government must do the same."
The letter noted that while public health programs account for roughly a third of the TGA's total work, only around 7% of its funding comes from public sources, with the remaining 93% drawn from fees and charges levied on industry.
"Funding for important public health measures and health emergencies should be provided by the Government, not cross-subsidised through TGA measures such as existing cost-recovery models," the authors said.
Drawing an unfavourable comparison with regulators in other countries — particularly the US Food and Drug Administration, which receives 54% of its funding from public sources — the signatories argued that the upcoming May federal budget was "the ideal opportunity to create a viable funding model for the TGA."
"If such public funding is not secured, it has the potential to diminish the Government's otherwise ambitious life sciences initiatives, weaken the life sciences ecosystem, and most concerningly, undermine the health of all Australians," the authors warned.
The letter was jointly submitted by AusBiotech, Medicines Australia, the Medical Technology Association of Australia, ANDHealth, BioMelbourne Network, Life Sciences Queensland, and Life Sciences WA.
