As counterfeit goods continue to infiltrate the dental supply chain, putting clinicians and patients alike both at risk, the Australian Dental Industry Association (ADIA) has endorsed legislative amendments that provide the Therapeutic Goods Administration (TGA) with stronger compliance and enforcement powers.
“The legislation before the parliament addresses ADIA’s longstanding 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 amends the Therapeutic Goods Act 1989 (Cth) to provide 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, they have been 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 and complex assessment not warranted for low-level breaches of the supply provisions within the legislation,” Williams said.
The legislation removes the requirement of the “likelihood of harm or injury to any person” from each strict liability criminal offense in the legislation, allowing the TGA to more readily issue infringement notices when instances of illegal supply can be proven.
The legislation with the change is set out in the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (Cth) 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 longstanding 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,” said Williams.
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