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

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TGA Seeks New Powers To Address Illegal Supply

TGA Seeks New Powers To Address Illegal Supply

2nd Jun 17

Summary —

The Australian Government is proposing legislative amendments that will allow it to effectively crack-down on illegal importers of dental products, such as those who import products via the internet.  This move, that will preserve the integrity of the TGA’s legislation and enhance patient safety, comes about following sustained political advocacy by ADIA.

Key Issues For The Dental Industry —

For a number of years the Australian Dental Industry Association (ADIA) has been working to enhance the ability of the Therapeutic Goods Administration (TGA) to effectively enforce its legislation when low-level breaches occur.  The Australian Government has proposed a series of reforms that would see the Therapeutic Goods Act (Cth) 1989 amended to strengthen the TGA’s hand in this area.

What Reforms Are Proposed —

It is proposed that the Therapeutic Goods Act (Cth) 1989 will be amended to give the TGA powers to more effectively deal with repeated low-level breaches of the legislation.  For more information visit:

TGA Consultation Paper - Enhancing sanctions and penalties [PDF] 

The reforms provide for graduated penalties that will allow the TGA to respond appropriately to the full range of non-compliance, from repeated minor breaches through to serious non-compliance.  

This is an important reform that will enhance patient safety by providing meaningful penalties associated with the illegal supply of dental products and other medical devices.  Such instances of supply may include a healthcare professional importing dental product then using this product on patients without first having placed the product on the Australian Register of Therapeutic Goods (ARTG), the TGA’s list of medical devices that can be lawfully supplied in Australia.

The challenge before the TGA in enforcing its legislation on those supplying medical devices outside the regulatory framework is that, as the legislation is currently worded, the penalties for such illegal activity are difficult for the TGA to apply.  The proposed amendments to the legislation will make it easier to deal with those that willfully and repeatedly ignore their obligations under the legislation.

Legislation That Made Enforcement Difficult —

The Therapeutic Goods Act (Cth) 1989 was amended in 2006 to introduce infringement notices as part of a series of changes to enforcement provisions. The challenge that the TGA faces is that these penalty notices can only be issued in circumstances where the illegal supply of medical devices would, if they were used, likely result in harm or injury to a person.  This requirement substantially undermines the use of infringement notices as an effective deterrent, as in many cases the products would not be likely to result in harm or injury to a person (e.g. when an identical product already appears on the ARTG) or the effort required for the TGA to prove this is not warranted in circumstances where a low-level breach is alleged.

ADIA has long argued that the legislative requirement where infringement notices can only be issued if the relevant goods, if used, would likely result in harm or injury to a person effectively makes this an ineffective deterrent insofar as low-level breaches of the legislation are concerned.  The Australian Government has accepted this advice from ADIA and, through the proposed reforms, is proposing to remove the additional test in the Therapeutic Goods Act (Cth) 1989 that the act of illegally supplying therapeutic goods would likely “result in harm or injury to any person”.

Pressing The Case For Reform —

Over the past several years, ADIA has been a strong advocate for reforms that would enhance patient safety and preserve the integrity of the TGA’s investigation and enforcement activities.  This has been something that, on behalf of its members, ADIA has progressed at both a parliamentary and departmental level.

In 2011 the Australian Government commissioned a review to improve the transparency of the TGA.  ADIA’s advice to this review was that the TGA should revise its procedures for investigating potential breaches of the legislation and that the process be strengthened to ensure that it is both transparent and that there is accountability.  The Australian Government’s final report arising from this review picked-up ADIA’s concerns and noted:

There is a public perception that the TGA’s investigations and compliance actions are ineffectual and rarely applied. [1]

Later that year as the Australian Senate Community Affairs Reference Committee considered the regulatory standard for medical devices, ADIA again took up the issue.  The focus was on the TGA’s enforcement activities with a specific reference as to how the procurement of dental products via the internet was a potential source of harm to patients.  In noting ADIA’s concerns, the Senate Committee made the following recommendation:

The committee recommends that the Therapeutic Good Administration carry out an investigation to ascertain whether importation of medical devices via the internet is adequately regulated. [2]

When the Senate Community Affairs Legislation Committee held an inquiry to review the Therapeutic Goods Amendment (2013 Measures No. 1) Bill (Cth) 2013 the Committee was given advice by ADIA that even a cursory examination of online auction sites such as eBay demonstrated that it is possible to purchase a range of medical devices into Australia, including some relatively high-risk devices such as sterilisers and tooth filling materials from markets such as China and India.

Each year ADIA convenes a meeting at Parliament House in Canberra which affords the dental industry’s senior leadership to meet with key Ministers, Shadow Ministers and key cross-benchers.  The issue of providing the TGA with effective enforcement powers has been a recurring theme in ADIA’s discussions with the parliamentarians in attendance.

The Last Step In Securing Reform

In October 2014 the Australian Government announced an independent review of medicines and medical devices regulation.  The Review examined the TGA Australia's medicines and medical devices regulatory framework and processes with a view to identifying, amongst other things, opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

Following consultations with the ADIA membership the dental industry tendered a number of recommendations, including that the arrangements pertaining to the use of infringement notices be revised to allow the TGA greater latitude to issue them in circumstances where a minor infringement of the Therapeutic Goods Act (Cth) 1989 is alleged.  In its final report, the review panel recommended:

That the Act should be re-drafted in such a way as to provide for graduated penalties that allow the [TGA] to respond appropriately to the full range of non-compliance from repeated minor breaches through to serious non-compliance. [3]

This was a significant break-through and came about after detailed conversations between ADIA and the panel undertaking the review; however, having the review panel make the recommendation was only the first step in achieving an outcome – the major challenge was to get the Australian Government to adopt it.

Soon after this report was announced ADIA met with the Minister for Health, the Shadow Minister for Medicare (who has opposition oversight of the TGA’s work) and made representations, individually and collectively, to all 226 members of the House of Representatives and the Senate.  The importance of accepting this recommendation to the dental industry is understood by any parliamentarian familiar with ADIA and the concerns of its members.

The outcome is that the Australian Government is acting, as ADIA has requested, to amend the legislation to empower the TGA to use infringement notices where minor breaches of the legislation can be proven.

The changes proposed by the Australian Government will improve patient safety and provide greater confidence in the TGA and the legislation it enforces.  It will provide the regulator with an effective way to sanction those who buy dental products online and then supply these products, or use them on patients, without first seeking TGA market authorisation.

This outcome has come about after a sustained campaign by ADIA that was driven by its members who encouraged the Association to press-on at times when progress was slow.  It is an important advocacy outcome that will enhance patient safety and strengthen the integrity of the medical devices framework.

Member Engagement —

On matters associated with dental product regulation the team in the ADIA national office receives advice and guidance from members serving on the ADIA-DRC Dental Regulation Committee.  Updates on the research are provided at the quarterly ADIA State Branch Briefings.  If your business has an interest in this matter, get involved today.

Further Information —

For further information from ADIA on matters associated with dental product regulation send an email to policy@adia.org.au 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 2 June 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. 
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This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, images and where stated.

 

 

[1] Review to improve the transparency of the Therapeutic Goods Administration [Dept Health, June 2011]
[2] The regulatory standards for the approval of medical devices [Senate Committee Report, Nov 2011]
[3] Report on the regulatory framework for medicines and medical devices [Dept. Health, Mar 2015]

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