TGA To Revise Penalties For Illegal Supply
28th Nov 16
The TGA is to revise the penalties associated with the illegal importation and / or supply of dental products to strengthen the integrity of the regulatory framework for medical devices. The reforms will provide new penalties for those buying products online and using these on their patients.
Key Issues For Consideration —
The regulatory arrangements associated with the supply of dental products and other medical devices require that these be placed on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied or used on patients in Australia. However, the enforcement provisions within the Therapeutic Goods Act (Cth) 1989 provide a less than ideal way to ensure compliance with the legal requirements which has led to a perception in some quarters that the Therapeutic Goods Administration (TGA) is unable to enforce the legislation for which it is responsible.
As a result of a sustained campaign undertaken by the Australian Dental Industry Association (ADIA) at a parliamentary and departmental level, the TGA is to act and review the penalties associated with the illegal importation and / or supply of dental products.
Use of infringement notices —
The TGA's use of infringement notices is particularly relevant to those who procure dental products and other medical devices from overseas and then use or supply them in a manner contrary to the regulatory framework.
ADIA has been a strong proponent for the TGA to issue infringement notices following a decision to take action against a person for non-compliance with a regulatory requirement when they purchase products from overseas via the Internet then use them on patients (without placing the the products on the ARTG). This option became available to the TGA as a result of 2009 amendments to the Therapeutic Goods Regulations (Cth) 1990 which gave effect to sections 42YJ and 42YK of the Therapeutic Goods Act (Cth) 1989.
An infringement notice gives the person to whom the notice is issued the option of either paying the penalty set out in the notice to expiate the office or contravention of a civil provision, or electing to have the matter taken to court.
Consistent with the TGA's commitment to transparency, a notice would be issued on the TGA's website with details of who received the infringement notice and why.
Challenges with the current system —
The TGA has found the current arrangements associated with the use of infringement to be impractical and therefore an ineffective deterrent. This is because the level of evidence required by the TGA is the same as that required for a court action, which in the case of a strict liability offence, involves prove beyond reasonable doubt that the use of the goods would be likely to result in harm or injury to a person.
ADIA has successfully argued that the current enforcement arrangements are flawed as it provides little deterrence for those that import then use dental products in a manner inconsistent with the TGA's regulatory framework. With the support of its members, ADIA was able to secure a commitment from the Australian Government, arising from the review into medicines and medical device regulation, to undertake a comprehensive review of the legislative framework for enforcement, including a review of the Therapeutic Goods Act (Cth)1989 and subordinate legislation in their entirety. This will provide recommendations on amendments to provide graduated penalties which will allow TGA to respond appropriately to the full range of non-compliance from repeated minor breaches through to serious non-compliance.
At the ADIA Parliamentary Roundtable held on 9 November 2016, the Association raised with the Minister for Health and Ageing, the Hon. Susan Ley MP, the need for the Australian Government to act on this matter.
A preliminary meeting between ADIA and the TGA has taken place which is the start of a rolling series of stakeholder consultations that are likely to see legislation introduced into the parliament in 2017 that will cement the reforms.
For some years the ADIA membership has expressed its frustration that the TGA's regulatory framework is "unenforced and unenforceable" as a representative of one member aptly described the current scenario. The changes will work to address this perception, providing the TGA with a set of tools to address what's viewed by regulators as low-level breaches such as those associated with buying dental instruments online and then using them on patients - this is illegal at the moment; however, the reform secured by ADIA will provide new penalties to address such non-compliance. This is viewed as a major policy win for the dental industry and an excellent example of what ADIA members can achieve when they come together to address matters where a shared interest arises.
This reform is a key outcome set out in the ADIA Advocacy Agenda and is part of ADIA's vision, set out in the 2016-20 ADIA Strategic Plan, for an industry that empowers oral health professionals to advance the health and well-being of all Australians.
Member Engagement —
Employees of ADIA member businesses come together under the auspices of the ADIA-DRC Dental Regulation Committee to review opportunities to strengthen the regulatory framework for the manufacturer and supply of dental products and provide advice and guidance to ADIA staff responsible for policy advocacy. Members are able to receive updates at the ADIA State Branch Briefings held each quarter.
Currency of Information —
This update was issued on 28 November 2016 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 publication 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.
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