Industry associations unite in joint call for Budget funding boost

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A coalition of Australia's life science industry associations has united in calling on the federal government to increase funding to the TGA.

The associations - Medicines Australia, AusBiotech, the Medical Technology Association of Australia, ANDHealth, BioMelbourne Network, Life Sciences Queensland and Life Science MA - have signed the joint letter sent to senior federal ministers.

It is unclear whether TGA head John Skerritt was consulted before the letter was sent.

The TGA provides regulatory services that are significantly cost-recovered but also many fee-free services for the "public good some of which do not directly relate to any particular product or industry group."

In the 2019-20 Mid-Year Economic Fiscal Outlook, the former federal government announced $33 million over four years and then $15 million per year from 2022-23 to enable the TGA to meet the cost of fee-free services that cannot be cost-recovered.

Yet according to the industry associations, the TGA's funding model remains "outdated" with a new injection of resources required to support "its worthy public health initiatives."

They point to a range of "positive" policies designed to support growth in the life sciences sector but describe them as being "at odds with the lack of sustainable federal funding" for TGA.

"The TGA is a central part of the Australian life sciences ecosystem and is considered a leading regulator worldwide.

"The agency has a vital role in safeguarding the health of the Australian public. Its role has evolved significantly over time to include a substantial amount of ‘public health activities’ beyond evaluating, assessing, and monitoring medicines and medical devices. The funding model has not evolved similarly.

"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.

"While these public health programs represent about a third of the TGA’s work, only about 7 per cent of the TGA’s funding is provided through public funds. The remaining 93 per cent of the TGA’s revenue is collected through industry fees and charges. 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."

They continue, "Compared to other comparable well-respected and effective regulatory agencies around the world, the TGA is alone in receiving such a small amount and percentage of public funding. In the United States, the Food and Drugs Administration (FDA) is 54 per cent funded through public funds. The equivalent for the European Union’s European Medicines Agency (EMA) is 13 per cent and 16.6 per cent for the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)."

The associations say a lack of funding risks diminishing the federal government's "otherwise ambitious life sciences initiatives" with the long-term risk of undermining health outcomes.

"The Federal Budget in May 2023 is the ideal opportunity to create a viable funding model for the TGA. Sustainable public funding for the TGA, commensurate with other similar national regulatory agencies, is in Australia’s national interest.

"By providing appropriate funding for the TGA in the Federal Budget, and reviewing the agency’s funding model in the medium-term, the Government has an opportunity 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."