ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

Media Release —
TGA’s New Medical Devices Tax Deserves Public Scrutiny


— 4 June 2018
For Immediate Release


As 1 July 2018 approaches so too does the commencement date for a new medical devices tax proposed by the Therapeutic Goods Administration (TGA); however, calls are gathering apace for the new tax to be subjected to public scrutiny. Amongst stakeholders calling for a review is the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of innovative dental products.

“The TGA’s new medical devices tax hits small businesses particularly hard, yet the TGA has yet to publish details of the proposed new tax on its website. There is no consultation document on the TGA's website, no Regulation Impact Statement available for comment, nothing at all to suggest that the proposed new tax is likely to kick-in on 1 July 2018,” said Troy Williams, ADIA Chief Executive Officer.

The TGA’s new medical devices tax will be levied on businesses that wish to place low-risk medical devices of the Australian Register of Therapeutic Goods (ARTG), the list of medicines and medical devices that can be lawfully supplied in Australia.

“To date the TGA has issued no consultation document for public review. There is nothing in the public domain about how the new $530 medical devices tax was calculated, how many businesses it will impact and how much revenue the Australian Government expects to collect,” Mr Williams said.

Stakeholders such as ADIA had been expecting the TGA’s proposals to be the subject of a Regulation Impact Statement (RIS) given the public commitments made by the TGA on its website about how the regulator consults with industry about the funds it extracts from industry. The RIS would have provided a degree of transparency as to how the TGA calculated the dollar value of its proposed new tax.

“When we asked for a copy of the RIS that the TGA’s website said the regulator was committed to producing, the TGA’s response was to remove that section of its website. Curiously, the TGA amended its website on 8 May 2018 – budget day – when the Australian Government was very pleased to be making other announcements about tax cuts,” Mr Williams said.

Acknowledging the technical debate as to whether the TGA’s proposal constitutes a fee or a tax, ADIA suggests that the proposal needs to be looked at in its entirety.

The increased funds that the TGA will be extracting from small businesses will be partially funding what any reasonable person would argue are the ordinary functions of government. These include public awareness campaigns, regulatory reform, departmental finance and audit activities plus enforcing sanctions and penalties. When business is being forced to pay for these functions, describing the revenues as a new tax is not without merit.

The TGA’s medical devise tax proposal is currently being considered by the Minister for Health.


Media Contact —

ADIA Communications Officer
t: 1300 943 094.....e:

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