AusBiotech submits feedback on TGA fees and charges consultation

AusBiotech has responded to the Therapeutic Goods Administration’s annual fees and charges consultation, urging the Government to reconsider how the TGA’s digital transformation is funded.

AusBiotech is supportive of the proposed fee increase of 4.7%, with the position in line with previous increases, and offering an approach where fees are commensurate with the opportunities for efficiency gains and is consistent with the Government’s policy for cost recovered activities.

However, it strongly recommends that the decision to fund the TGA’s digital transformation through increases to cost recovery arrangements is reconsidered.

The TGA is currently undergoing a digital transformation to enhance their business systems, including the establishment of a ‘single product portal’. And the consultation paper explains that to cover the long-overdue digital update, costs will be recovered from industry over five years, commencing from 1 January 2024.

AusBiotech’s Director Policy & Communications Karen Parr noted, “Industry is very supportive of the modern operating system that the digital update offers, and has been involved in the UDI system consultations for many years. However, the Australian Government’s cost recovery guidelines are clear that industry fees and charges should accurately reflect the fee for services provided directly to a specific individual or organisation.

“AusBiotech is yet to learn of any other government body, even those undertaking cost recoverable activities, that puts the costs of infrastructure updates onto its stakeholders. AusBiotech strongly recommends that the decision to fund the TGA’s digital transformation through increases to cost recovery arrangements is reconsidered.”

AusBiotech welcomed the Government’s additional funding for four years of public good activities in the 2023-2024 Federal Budget. As an internationally competitive regulator, Australia needs an agency that is empowered to contribute to the Australian economy and to the life sciences sector.

In light of this funding, it recommended the development and publication of metrics to demonstrate the value that this publicly-funded public good activities are delivering to Australians and Australia.

The TGA is world-class and plays a vital role in safeguarding the health of the Australian public, however its remit has evolved significantly and now includes a meaningful amount of ‘public health activities’ such as consumer education and the regulation of cannabis products, that go beyond evaluating, assessing and monitoring medicines and medical devices through which it collects its fees and charges.

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 development of metrics will support attaining sustainable public funding for the TGA that is commensurate with other similar national regulatory agencies, and that is in Australia’s national interest.

Submissions in response to this public consultation will be considered as part of the decision making of fees and charges for 2024-25, with the final consultation outcome to be published on the TGA website.

The AusBiotech submission was developed with the support of the AusMedtech Regulatory Affairs Advisory Group. Read AusBiotech’s submission here.

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