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Submissions received: Fees and charges proposal 2020-21

23 June 2020

On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, Fees and charges proposal 2020-21. The purpose of this consultation was to provide industry and other stakeholders with an opportunity to comment on options for changes to fees and charges for 2020-21. The consultation closed on 28 February 2020.

A total of 8 submissions were received, including six from peak industry bodies. We thank those individuals and organisations who lodged submissions for their valuable contribution. This feedback has been taken into consideration as part of the approval process for the 2020-21 fees and charges.

All submissions that gave permission to be published on the TGA website are available below in PDF format. Two of the individuals/organisations only wished to publish their names and work titles; one organisation wished to publish some parts of their submission.

Submissions received

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Half of submissions supported an indexation increase to the TGA fees and charges based on the Consumer Price Index (CPI) and the Wage Price Index (WPI). These included three submissions from industry bodies and one from a global biotech company. Two industry bodies in the medical devices sector were not supportive of any increase due to the increasing cost of doing business and inability to pass such costs to their customers to remain competitive in the market. In the medicines sector, an industry body supported the indexation based increase at the bilateral meeting in December 2019 however in their consultation submission requested not to apply any increase in because of the likely impact of COVID-19 on business and economy. A non-profit organisation requested to consider no further fee increases for not for profit academic organisations conducting clinical trials.

After consideration of the submissions, the Government approved the indexation based increase of 1.95% to all fees and charges, subject to rounding. This is significantly lower than the 4.3% increase that would be required to cover the known costs increase for 2020-21. The indexation increase is not only consistent with the long-standing practice, which provides the stability for business planning and ensures that TGA's provision of services are kept up with the current standard. This also provides opportunities for efficiency gains through business process improvement.

Additionally, the proposal to rationalise the fee structure for obtaining the Secretary's consent to supply the therapeutic goods that do not comply with applicable standards has also been approved by the Government. The implementation of fee of $8,570 for early scientific advice (optional step for sponsors) is subject to the passage of the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 which is currently before the Parliament.