TGA gets tough on sponsors who fail to comply with advertising rules

Sponsors beware!  The TGA may now publicise a failure to comply with advertising rules for therapeutic goods.

In Australia, the advertising of therapeutic goods to consumers is regulated by the Therapeutic Goods Advertising Code (as well as the Therapeutic Goods Act, Therapeutic Goods Regulations and Australian Consumer Law).  The TGA Complaints Resolution Panel (“CRP”) is charged with investigating complaints where it is alleged that an advertisement breaches the Advertising Code (or the Act and Regulations).  The CRP will decide whether or not the complaint is justified and issue a decision, which can request that the sponsor do certain things such as withdraw the advertisement or publish a corrective statement.

If a sponsor fails to comply with the CRP’s request, the CRP can then recommend that the TGA make certain orders, including an order to withdraw the advertisement and publish a corrective statement.  The TGA is empowered to investigate and, where necessary, take appropriate action.  Until now, the TGA has not published the outcome if its investigations.  However, in response to the recent TGA Transparency Review, the regulator has now begun publishing details of its investigations where the CRP has referred a matter to it for follow-up.

The first two decisions of the TGA were published on 3 August and can be found here.

The TGA has stated that “[p]ublication of the outcome of TGA investigations is intended to provide guidance to advertisers on how the advertising requirements are interpreted and actions taken by the TGA in relation to advertising breaches.”  The TGA’s change in practice also serves as an important motivator for sponsors under investigation by the CRP to act promptly and comply with any requests issued by the CRP or, alternatively, be proactive in dealing with the TGA where a matter is referred to the TGA.

About the Author

James Ellsmore
James is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.
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