Dental Regulation Projects — Advertising therapeutic goods

The Australian Dental Industry Association (ADIA) is supporting the Therapeutic Goods Administration (TGA) in the development of options to enhance the operation and effectiveness of the therapeutic goods advertising regulatory scheme

The review was commissioned to address  concerns about unfounded efficacy claims used in advertisements. The current pre-approval system is limited in its ability to prevent consumers from being exposed to advertisements for therapeutic goods that contain misleading claims related to the treatment of serious medical conditions, because only a sub-set of products are covered and only a sub-set of advertising media is covered by the current arrangements.  The Australian Government also considered it appropriate to address concerns consumers view the advertising complaints system as cumbersome and slow, with multiple processing pathways, procedures and resolution bodies depending on the nature of the complaint, the type of therapeutic good, the advertising media involved and the target audience for the advertisement.

In November 2010, the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, chaired a meeting of key stakeholders to discuss this feedback and ways to improve the regulation of therapeutic goods advertising and ADIA was represented at this meeting that was held at Parliament House, Canberra. The meeting agreed that the TGA should develop options for improvements to the arrangements for the pre-approval of advertisements, the complaints resolution system and sanctions and penalties for non-compliance with the advertising requirements.  As part of the consultative arrangements ADIA tendered a submission on behalf of the dental industry.

Key documents —
     Australian Government – Consultation paper on advertising therapeutic goods  [PDF]
     ADIA Submission - Advertising therapeutic goods [PDF]
     Australian Government Policy Response - 2011 TGA Reform blueprint [PDF]

In Australian advertisements for therapeutic goods are generally subject to the requirements and limitations of the Therapeutic Goods Act (Clth) 1989 and supporting subordinate legislation. Some advertisements for selected goods are subject to self regulation by industry bodies. The Australian Government has proposed changes to achieve a regulatory framework for the advertising of therapeutic goods that is more efficient, effective, transparent and consistent that the current system. 

ADIA has maintained a policy position that allows the Australian Government to achive the desired policy objectives while at the same time freeing the dental industry from an unnecessary regulatory burden.

The arrangements largely pertain to the advertising of medicines, however the Australian Government has also considered medical devices in a new regiment that may consider all forms of advertising, including that in the print media, electronic media and in-store promotion. Also under review is the complaints handling mechanism and the sanctions that may apply when the new rules have been breached.

Australian Government's Policy Response  —

The TGA will work to improve current arrangements for the regulation of therapeutic goods advertising, including a central point for all complaints about advertising will be created at the TGA. Some complaints will be handled directly by the TGA. Specifically, complaints regarding efficacy or the intended purpose of therapeutic goods, or for advertisements which could pose a significant risk to public health will be dealt with directly by the TGA without reference to the Complaints Resolution Panel.

Policy Outcome:  In-principle agreement to modify the pre-approvals process to include medical devices and pay television so that advertising claims about the efficacy of a product to be assessed by the TGA, with further consultation to be undertaken with key stakeholders, include ADIA.

Policy Outcome:  Establish a single entry point for all complaints, with some handled by TGA (complaints about the efficacy of a product to be assessed by the TGA). 

Policy Outcome:  The Australian Government will look at options to introduce more effective approaches to sanctions and penalties, including use of the infringement notice provisions, in consultation with stakeholders including ADIA.

It is understood that there is currently a lack of incentive to comply with regulatory requirements. The currently available sanctions and penalties that can be imposed as a consequence of non-compliance with advertising requirements have been criticised for not providing a sufficient deterrent. These sanctions and enforcement strategies involve significantly lower pecuniary penalties compared to other comparative breaches of the Act.

In order to ensure that there is broad understanding of what is proposed in this area, and in the interests of fostering stronger relationships amongst key stakeholders, ADIA has provide a brief to the Australian Dental Association (ADA) on this issue

ADIA’s response and ongoing input is being coordinated by the ADIA-DRC Dental Regulation Committee.

To keep up to date with changes on this issue follow ADIA on Twitter @AusDental or contact the ADIA National Office via email at dental.regulation@adia.org.au or by telephone on 1300 943 094 (internationally on +61 2 9319 5631).