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 Reforms Deal Effectively With Illegal Supply

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— 24 January 2018
For Immediate Release

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Proposed legislative amendments that provide the Therapeutic Goods Administration (TGA) with stronger compliance and enforcement powers have been endorsed by the Australian Dental Industry Association (ADIA), the peak business organisation representing dental product manufacturers and suppliers.

“The legislation before the parliament addresses ADIA’s long-standing concerns about patient safety arising from the illegal supply of dental products. The fact that the Australian Government has responded to ADIA’s concerns by giving the TGA greater enforcement powers is a great outcome for patients and the broader dental community,” said Troy Williams, ADIA Chief Executive Officer.

The legislation before the parliament amends the Therapeutic Goods Act 1989 (Cth) in a way that provides the TGA with a greater range of powers to deal with the illegal supply of dental products and other medical devices. Although infringement notices are currently available to the TGA as an alternative to pursuing litigation when instances of illegal supply could be proven, these were rarely applied.

“The challenge is that the TGA could only issue an infringement notice if the relevant goods, if used, would likely result in harm or injury to a person. The TGA has found that this often requires a burdensome often complex assessment not warranted for low-level breaches of the supply provisions within the legislation,” Mr Williams explained.

As a result of ADIA’s advocacy, the legislation removes the requirement of the "likelihood of harm or injury to any person" from each strict liability criminal offence in the legislation, thus allowing the TGA to more readily issue infringement notices when instances of illegal supply can be proven.

The legislation containing the change is set out in the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (Cth) that is currently being reviewed by the Senate’s Community Affairs Legislation Committee. In a submission to the Senate Committee, ADIA has argued that the legislation should pass.

“Securing this legislative reform has been a long-standing priority for ADIA. With greater enforcement powers, the TGA will be able to better protect patient safety when instances of illegal dental product supply can be proven,” Mr Williams said.

Ends.

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Media Contact —

Chris Jaeger
ADIA Communications Officer
t: 1300 943 094.....e: media@adia.org.au

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