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TGA reforms: A blueprint for TGA's future

25 September 2014

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Advertising of therapeutic products to the general public

Current regulatory arrangements for advertising therapeutic goods

The advertising of therapeutic goods to consumers and health practitioners is controlled by a combination of statutory measures administered by the TGA and self-regulation through Codes of Practice administered by the relevant therapeutic goods industry associations. Advertising to consumers is permitted for the majority of medical devices and medicines available for over the counter sale, while advertising prescription-only and certain pharmacist-only medicines to the general public is prohibited.

Advertisements for therapeutic goods in Australia are subject to the requirements of the Act and Regulations, the Competition and Consumer Act 2010 and other relevant laws. Advertisements directed to consumers must also comply with the Therapeutic Goods Advertising Code with certain advertisements directed at consumers requiring approval prior to broadcast or publication.

The responsible use of advertising provides one mechanism to enhance the health outcomes of Australians.

Issues

Current calls for a more robust and effective system for the regulation of therapeutics advertising that ensures consumer confidence, and provides a level playing field for industry, have been noted.

The regulatory framework for advertising therapeutic goods has been the subject of a number of reviews over the past decade. The current framework has more recently been the subject of public criticism around misleading advertising of therapeutic goods and the potential consequential risks to public health. This criticism has focused mainly on the scope of the pre-approval process, the timeliness of the complaints handling process and that the available sanctions and penalties do not provide sufficient deterrence.

In June 2010, the TGA released a consultation paper seeking feedback on options to enhance the operation and effectiveness of the therapeutic goods advertising regulatory scheme.

Criticisms of therapeutic goods advertising included:

  • 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;
  • a lack of clarity about complaints processes. 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; and
  • 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.

Progress to 31 December 2014

Progress in implementing the Blueprint recommendations is provided in TGA Reforms: A blueprint for TGA's future Progress Report as at 31 December 2014. This report provides details of progress against the 48 recommendations to be implemented by the TGA during the four year program. In addition, the report highlights the expected benefits for Advertising of therapeutic products to the general public.

Progress of remaining Blueprint recommendations

In October 2014, the Australian Government announced the Expert Review of Medicines and Medical Devices Regulation (Expert Review). Progress of some reforms proposed in the Blueprint is dependent on the outcome of the Expert Review and the Government's response to the findings.

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