AusBiotech advocates for sustainable funding model for TGA


AusBiotech has united with industry groups to urge the Government to retain and empower Australia’s world-leading regulator by addressing the outdated funding model it operates under, and to fund its worthy public health initiatives through the upcoming Federal Budget. 

In its joint Federal Budget letter, AusBiotech, Medicines Australia, the Medical Technology Association of Australia, ANDHealth, BioMelbourne Network, Life Sciences Queensland, and Life Sciences WA have emphasised that the Therapeutic Goods Administration (TGA)’s current funding model – which is predominantly cost-recovered by industry - is outdated, no longer works for the needs of Australian society and should be brought in line with the models of comparative markets such as the FDA in the US and the EMA in Europe.

While AusBiotech has previously welcomed Government’s commitment to build on the strength of the Australian life sciences industry through ambitious initiatives, such as the $15 billion National Reconstruction Fund (NRF), the Trailblazer Universities Program to support select regional universities to boost research and development, and the establishment of an Australian Centre for Disease Control (CDC), these are at odds with the lack of sustainable federal funding for the TGA.

The TGA plays a vital role in safeguarding the health of the Australian public, however, its remit has evolved significantly and now includes a significant amount of ‘public health activities’ that go beyond evaluating, assessing and monitoring medicines and medical devices. This work now includes management of medicine shortages, providing education to consumer and healthcare professionals, regulation of cannabis products, and management of nicotine vaping products.

Yet the funding model has not evolved to take these new activities into account. While these public health programs represent about a third of the TGA’s work, only about 7% of the TGA’s funding is provided through public funds. The remaining 93% of the TGA’s budget is funded through industry fees and charges. Compared to other well-respected and effective regulatory agencies around the world, the TGA is alone in receiving such a small amount and percentage of public funding.

AusBiotech fully supports the essential public health work that the TGA currently undertakes and urges the Government to do the same by providing appropriate funding for its work.

The Government has an opportunity in the next Federal Budget to enable the TGA to strengthen its position as a globally leading regulator, stay up to date with the increasing pace of innovation, and respond quickly to future health emergencies. 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.

Download the joint submission on the AusBiotech website here