ANAO To Review Proposed Medical Devices Tax
27th Apr 18
At the request of the dental industry the Australian National Audit Office (ANAO) will review proposed new imposts that the Therapeutic Goods Administration (TGA) wishes to place on innovative dental product manufacturers and suppliers.
Key Issues For The Dental Industry —
As the TGA looks set to impose additional costs on businesses that supply low-risk medical devices, the ANAO has invited the Australian Dental Industry Association (ADIA) to set out industry’s concerns with respect to the lack of public consultation on the proposals.
The apprehension within the dental industry, and the medical technology sector more broadly, rests with a proposal from the TGA that business, for the first time, pay a fee to place low-risk medical devices on the Australian Register of Therapeutic Goods (ARTG), the list of medicines and medical devices that can lawfully supplied in Australia. ADIA has been briefed on the proposal; however, what has become clear is that stakeholders across the medical devices sector are concerned about the lack of public consultation with the proposal.
ADIA is of the view that when it comes to stakeholder consultation the TGA’s processes and commitment to engaging not only with the dental industry, but also the broader medical devices sector, are first-rate. Indeed, ADIA has publicly stated the regulator acts as an exemplar for other Australian Government department and agencies; however, when it comes to the proposed Australian Government charges to business to place low-risk medical devices on the ARTG, the lack of public consultation is of concern.
The proposal to charge a $530 application fee to place low-risk medical devices on the ARTG will, according to small businesses across the dental industry, make it commercially unviable to introduce a range of innovative products to the Australian market, thus depriving dentist and allied oral healthcare professionals with access to the products used in dental and oral health care.
ADIA raised concerns about the TGA’s proposals with the ANAO which has responded quickly, inviting the nation’s peak business organisation representing innovative dental product manufacturers and suppliers to tender advice on the TGA’s proposal and consultative process.
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 given that the money 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.
Member Engagement —
On matters associated with dental product (medical device) regulation the policy advocacy team within the ADIA National Office receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee. Frequent updates are provided to members that attend the quarterly series of ADIA State Branch Briefings.
Further Information —
For further information on ADIA's efforts to reduce the regulatory compliance burden on businesses across the sector firstname.lastname@example.org or telephone 1300 943 094. To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.
Currency Of Information & Disclaimer —
This update was issued on 27 April 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
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