TGA Reforms Deal Effectively With Illegal Supply
24th Jan 18
Proposed legislative amendments that provide the Therapeutic Goods Administration (TGA) with stronger compliance and enforcement powers and graduated penalties for non-compliant behaviours have been endorsed by the dental industry.
Key Issues For The Dental Industry —
Addressing long-standing concerns about patient safety arising from the illegal supply of dental products, the Australian Government has introduced into the parliament legislation that will give the Therapeutic Goods Administration (TGA) stronger compliance and enforcement powers.
The change comes about following sustained advocacy by the Australian Dental Industry Association (ADIA) which has long argued that the TGA lacked teeth when it came to dealing with issues of illegal supply. ADIA’s engagement with parliamentary and departmental stakeholders produced an Australian Government commitment that consideration be given as to whether the current range of investigation and enforcement powers under the Therapeutic Goods Act 1989 (Cth) should be broadened.
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 and often complex assessment not warranted for low-level breaches of the supply provisions within the Therapeutic Goods Act (Cth) 1989. 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). ADIA has been extensively engaged in the development of this legislation, meeting with the TGA as the reforms were developed. ADIA also provided comment on the exposure draft when it was released in mid-2017 and met with the TGA before the legislation was presented to the House of Representatives in September 2017. The Bill was passed by the House in December 2017 and introduced into the Senate that same month.
The Senate referred the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 to the Senate Community Affairs Legislation Committee for inquiry and report. It was in response to this inquiry that ADIA advised the legislative reforms enjoy the full support of the dental industry:
Securing this legislative reform has been a long-standing priority for ADIA. The catalyst for change was the 2014 expert review of medicines and medical device regulation commissioned by the Australian Government which, as a result of ADIA’s policy advocacy, recommended legislative amendments that would provide the TGA with graduated penalties to respond to the full range of non-compliance from repeated minor breaches through to serious non-compliance. This built upon earlier momentum on the issue generated between 2011 and 2014 when, as a result of ADIA’s representations, several Senate committees identified the need to strengthen the TGA’s legislative powers.
The need for reform was also canvassed during 2017 when ADIA met with the Minister for Health and other stakeholders at the dental industry's annual parliamentary roundtable in Canberra.
Member Engagement —
On matters associated with dental product regulation the team in the ADIA national office responsible for policy advocacy receive advice and guidance from employees of member businesses serving on the ADIA-PRPC Product Regulation Policy Committee. Member updates are provided at the quarterly series of ADIA State Branch Briefings.
Further Information —
For further information on ADIA's advocacy to strengthen the regulatory framework for dental products send an email to 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 24 January 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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