AusBiotech urges a Federal Government review of the TGA funding model, as it prepares its response to the annual TGA fees and charges proposal released last week.
The Government is proposing to substantially increase TGA fees and charges for pharmaceutical and medical technology companies in order to recover the increased costs its facing, including through its digital transformation and public good activities.
AusBiotech has been advocating for an overhaul of the current outdated funding model, including uniting other life science industry bodies to write to the Treasurer, and Ministers for Finance, Health and Aged Care, and Industry and Science as part of a pre-Budget submission. Increasing charges to the industry risks jeopardising the strength and competitiveness of the Australian healthcare sector, and the subsequent health of all Australians.
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. In addition, it is undergoing a digital transformation to enhance its business systems, including the establishment of a ‘single product portal’.
It is proposed that costs are passed onto the industry by increasing the fees and charges for services substantially. It is clear that the current funding model – where 92 per cent of the TGA’s costs are recovered from industry - has not evolved to take these new activities into account. While these public health programmes represent about a third of the TGA’s work, only about 8 per cent of the TGA’s funding is provided through public funds. 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.
AusBiotech is working with its AusMedtech Regulatory Affairs Advisory Group and AusMedtech Advisory Group as it responds to this consultation.