TGA Seeks Enhanced Penalties To Address Illegal Supply
20th Jul 17
Proposed reforms that will allow the Therapeutic Goods Administration (TGA) to more effectively deal with instances of illegal supply of dental products have been backed by the dental industry.
Key Issues For The Dental Industry —
Following extensive lobbying by the Australian Dental Industry Association (ADIA), the TGA is proposing a substantial overhaul of its enforcement framework. The intended outcomes of the reforms will provide the TGA with an expanded suite of possible regulatory actions to ensure that enforcement actions are proportionate with the risk that the therapeutic goods pose and to address any potential health and safety issues to the Australian public.
ADIA has been a long-standing proponent of the reforms that will allow the TGA to more effectively deal with those who import dental products then illegally supply and / or use them on patients. This is typically facilitated through health professionals purchasing dental products from overseas websites.
Alignment With Other Regulator’s Framework —
The TGA’s sanctions and penalties framework will be aligned with those in the Regulatory Powers (Standard Provisions) Act (Cth) 2014. This legislation provides for a framework of standard regulatory powers to be exercised by agencies across the Commonwealth on matters such as monitoring and investigation powers, as well as enforcement provisions through the use of civil penalties, infringement notices.
Use Of Infringement Notices —
Infringement notices are currently available to the TGA as an alternative to us pursuing litigation for breaches of strict liability criminal offences and contraventions of civil penalty provisions set out in the Therapeutic Goods Act (Cth) 1989. The legislation currently provides for penalty unit amounts for infringement notices in relation to strict liability criminal offences which are one fifth of the maximum penalty amount for an individual and five times that amount for an incorporated body.
ADIA has previously drawn to the attention of the Minister for Health and other parliamentarians a flaw in the legislation. This is that that there is a requirement for many strict liability offences that a penalty can only be applied 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. Accordingly, it is proposed to remove the requirement of the "likelihood of harm or injury to any person" from each strict liability criminal offence in the legislation.
This change provides the TGA to more effectively deal with low-level breaches of the legislation.
Advertising Reforms —
The TGA is also proposing a series of advertising reforms including the use of substantiation notices. These would allow the TGA to seek information from a manufacturer or supplier that would help the TGA to determine whether further investigation is warranted. These would be issued to people who have therapeutic goods included in the ARTG who place advertisements for their goods. Substantiation notices also apply to people who do not have goods in the ARTG, but place advertisements for therapeutic goods regardless of whether they distribute the goods by wholesale, retail or online.
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 TA 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. Further information on the TGA's proposed reforms and the detailed advice from ADIA to the TGA on this matter can be viewed by downloading the following documents:
Therapeutic Goods Enforcement Consultation —
TGA Consultation Paper - Enhancing sanctions and penalties [PDF] †
ADIA Submission - Supporting stronger sanctions and penalties [PDF] †
Reform in this area has been a long-standing priority for the ADIA membership and an issues that the Association has taken up with parliamentary and departmental stakeholders over a number of years. That the TGA has, as a result of sustained advocacy by the dental industry, embarked on reform is a great outcome achieved as a result of the support and guidance that ADIA staff have received by members serving on the ADIA-PRPC Product Regulation Policy Committee. If this is of interest to you get involved today.
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 the regulatory issues associated with therapeutic product regulation, ADIA members convene under the umbrella of the ADIA-PRPC Product Regulation Policy Committee to provide advice and guidance to ADIA's policy advocacy team. Updates are also provided at the quarterly series of ADIA State Branch Briefings.
Further Information —
If you have an interest in ADIA's efforts to reform the regulatory standards for equipment installation, for updates 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 20 July 2017 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 information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
† To access this file you will need your ADIA Member Plus log-in details. Contact membership@adia,org.au for support
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