The Australian Small Business and Family Enterprise Ombudsman (ASBFEO) has called for a delay in the introduction of the proposed new medical devices tax. It’s a move welcomed by the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of innovative dental products.
The proposed new medical devices tax will be levied by the Therapeutic Goods Administration (TGA) on all businesses looking to place low-risk medical devices on the Australian Register of Therapeutic Goods (ARTG), the list of medicines and medical devices that can be lawfully supplied in Australia. The TGA has undertaken no public consultation with regards to the new tax.
The TGA must, under guidelines published by the Department of Finance, prepare a Regulation Impact Statement (RIS) when seeking to change policy by introducing a new fee. As part of the standard Australian Government procedure, the TGA would publish the RIS on its website and make this available for public comment. The TGA has not done so with regards to the new tax.
Similarly, the TGA must consult with industry stakeholders about the content of the Cost Recovery Implementation Statement (CRIS) before the new medical devices tax is placed on its website. Again, the TGA has not done so with regards to the new tax.
"Small businesses across the dental industry, and medical devices sector more broadly, will be hit hard by this new tax and public consultation would have provided these businesses with the opportunity to explain this to the TGA. It’s most disappointing that small businesses have been denied the chance to comment on the impact of the TGA’s new tax," said Troy Williams, ADIA Chief Executive Officer.
It is in this context that ADIA has welcomed the intervention of the ASBFEO which has asked that the introduction of the new medical devices tax be placed on hold so that a review of the TGA's approach to consultation can be made.
The ASBFEO’s request to the TGA comes as a growing coalition of industry associations in the medical devices sector call for the introduction of the new tax to be delayed. These include the Assistive Technology Suppliers Australasia (ATSA), the Optical Distributors & Manufacturers Association (ODMA) and the Australian Medical Devices and Distributors Association (AMDDA) which have joined the ADIA in calling for proper consultation on the proposed fee.
The ADIA Chief Executive Officer, Troy Williams, has been called to Parliament House this week to provide a further series of briefings as to how this tax will impact the dental industry, and the medical devices sector more broadly.
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