The Federal Electorates Hit By The Medical Devices Tax
8th Jun 18
A new analysis of the new medical devices tax lists the twenty federal electorates with largest number of businesses that will be affected by this new impost on supplying innovative medical devices.
Key Issues For The Dental Industry —
The Therapeutic Goods Administration (TGA) is proposing that, for the first time, businesses that manufacture and supply low-risk medical devices will be required to pay an application fee – a kind of one-off medical devices tax – for placing these products 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 not prepared a public consultation paper that sets out the reason for the proposed new tax or how much revenue the Australian Government expects to collect as a result of its introduction. However, the TGA’s proposed new medical devices tax has been extensively reviewed by the Australian Dental Industry Association (ADIA), the peak business organisation representing manufacturers and suppliers of innovative dental products.
ADIA’s analysis includes identifying the number of businesses that will be impacted by the new tax and where they are located, including by Federal Electorate. In terms of number of businesses affected by the TGA's proposed new tax, the top twenty most impacted federal electorates are:
■. Bennelong (NSW)
■. Sydney (NSW)
■. North Sydney (NSW)
■. Chisholm (VIC)
■. Mitchell (NSW)
■. Mackellar (NSW)
■. Melbourne Ports (VIC)
■. Bradfield (NSW)
■. Aston (VIC)
■. Reid (NSW)
■. Isaacs (VIC)
■. Melbourne (VIC)
■. Brisbane (QLD)
■. Deakin (VIC)
■. Wentworth (NSW)
■. Berowra (NSW)
■. Kingsford Smith (NSW)
■. Curtin (WA)
■. Hotham (VIC)
John Alexander MP (LIB 4.9%).
Tanya Plibersek MP (ALP 13.3%).
Trent Zimmerman MP (LIB 13.6%).
Julia Banks MP (LIB 1.2%).
Alex Hawke MP (LIB 17.9%).
Jason Falinski MP (LIB 15.7%).
Michael Danby MP (ALP 1.4%).
Paul Fletcher MP (LIB 21.0%).
Alan Tudge MP (LIB 8.6%).
Craig Laundy MP (LIB 4.6%).
Mark Dreyfus MP (ALP 5.7%).
Adam Bandt MP (GRN 18.5%).
Trevor Evans MP (LNP 5.9%).
Michael Sukkar MP (LIB 5.7%).
Malcolm Turnbull MP (LIB 17.8%).
Julian Leeser MP (LIB 16.5%).
Matt Thistlethwaite MP (ALP 8.6%).
Julie Bishop MP (LIB 20.7%).
Clare O'Neil MP (ALP 7.5%)
Of the twenty seats with the most businesses affected by the tax, thirteen are held by the Coalition Government including the Prime Minster's seat of Wentworth and the Minister for Small and Family Business' seat of Reid. The list includes six seats held by the Labor opposition and one by the Australian Greens.
ADIA members have advised that the TGA’s proposed new application fee will create a significant barrier to market entry for entrepreneurs investing in new dental supply businesses which will be forced to pay $530 for every low-risk product entry. In order to compete in the dental product supplier sector, it is typically necessary for businesses to offer a wide range of products. A new business may need to apply for between twenty and fifty low-risk medical device entries from the outset. This means that new businesses face an additional upfront cost of $10,600 to $26,500.
It is important to note that the proposed $530 application fee will be in addition to the annual charge of $80 (increasing to $90 from 1 July 2018) that business must pay the TGA.
Member Engagement —
ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. With respect to policy advocacy efforts to reduce the red-tape associated with the manufacture and supply of innovative dental products, the team in the ADIA national office receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
To keep up to date with the latest market statistics subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at email@example.com or by telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 8 June 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.
This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, images and where stated.
2nd Jul 18
Importers of dental laboratory products are being encouraged to review Australia’s regulatory standards to ensure their suppliers are aware of the design and construction principles that protect patient safety.
26th Jun 18
The Australian Small Business and Family Enterprise Ombudsman (ASBFEO) has called for a delay in the introduction of the new medical devices tax so that its impact can be fully assessedd