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15 Sep 2015 | Press Release

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TGA’s Increased Fees Reduce Competition For Dental Products

Regulatory Affairs TGA

The range of dental products available to the Australian market is diminishing as a direct result of the Therapeutic Goods Administration's (TGA) botched attempt to reduce regulation of medical devices. This is the outcome of reports that the peak business organisation representing dental product manufacturers and suppliers, the Australian Dental Industry Association (ADIA), has received from member businesses.


"Businesses across the dental industry are withdrawing products from the market as a result of the TGA's new fee regime that was introduced this financial year. The result of the TGA's changes is reduced competition in the sector with dental professionals having a diminished range of products to choose from, which means reduced patient care options," said Troy Williams, ADIA Chief Executive Officer.

This adverse outcome is a result of charges business pays to place product on the Australian Register of Therapeutic Goods (ARTG), which is maintained by the TGA, and is a list of medicines and medical devices that can be lawfully supplied in Australia. Until 30 June 2015, a business could apply for an exemption to this charge if the value of products sold was fifteen times or less the charge that would have been payable to the TGA; however, the threshold where a business is eligible to claim an exception for the charge dropped to $0 from 1 July 2015. The trade-off is a small reduction in compliance paperwork; however this does not take into account the significantly increased charges that many small businesses in the dental industry will pay.

"Faced with paying the higher TGA fees, businesses across the dental industry are taking products off the ARTG with the result that the products cannot be lawfully supplied by these businesses in Australia. This is not the preferred course of action by these businesses, but the TGA's higher fees now means that it is not commercially viable to keep supplying these products to dentists," Mr Williams said.

ADIA is in active dialogue with the Assistant Minister for Health and is seeking an independent review of the TGA's new charges. This review should be used as the basis for a more equitable TGA charges framework next financial year.

"The TGA has stated that its new fee structure was intended to reduce business compliance costs, yet the experience of businesses across the dental industry is very different. An independent review to assess the full impact is required in order to provide the basis for a more equitable TGA charges framework next financial year," Mr Williams concluded.

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