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The first six months: embedding the TGA advertising reforms

25 January 2019

There have been many important developments in therapeutic goods advertising regulation over the last six months. This update provides a recap of some of the TGA's key achievements and outlines what we will focus on next.

We introduced a new advertising code

The Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) came into effect on 1 January 2019, replacing and updating the previous advertising code. We consulted extensively during the development of the Code and revised a number of aspects of the Code in response to the feedback we received.

We offered comprehensive training and resources

The new advertising hub on our website is a comprehensive source of information about the regulation of therapeutic goods advertising in Australia. Among other resources, it includes an online complaints form and guidance for advertisers.

In the lead up to 1 January we held a series of face to face training sessions and webinars to help advertisers understand what is expected under the new Code. The resources we provided during these events, including presentation transcripts, are available on our website along with an e-learning module on the regulation of therapeutic goods advertising.

We have also improved the information available for consumers about the advertising framework, including a consumer guide to the advertising requirements, 10 things to look out for in medicine advertisements and information on how to lodge a complaint about advertising.

The Minister appointed the Therapeutic Goods Advertising Consultative Committee

In October 2018 we held the first meeting of the Therapeutic Goods Advertising Consultative Committee. The Committee includes representatives from consumer, health professional, industry, media and government bodies. It provides input and advice on a range of matters, including the administration of the Code, emerging issues, complaints handling and reporting, and education and compliance priorities. Information on the committee and a summary of the first meeting is available on our website.

We are embedding a new risk-based approach to handling advertising complaints

In July 2018, the TGA assumed responsibility for handling all complaints about therapeutic goods advertising. Prior to this, advertising complaints were considered by multiple bodies. The new arrangement provides a simpler and more consistent system for both advertisers and consumers.

As part of taking on sole responsibility for handling advertising complaints, we introduced a new risk-based complaints handling approach. This approach means that we focus our efforts on the advertising issues that pose the greatest risks to public health and safety.

We categorise complaints into one of four risk categories: low, medium, high, and critical. Our categorisation takes into account various factors, including both the health and safety risk associated with the advertisement and the compliance history of the advertiser. For low level complaints we take a more educative approach by reminding advertisers of their obligations and providing them with full details of the complaint and our concerns. In addition a number of low level cases will be selected for assurance review as part of our broader compliance program. We direct our strongest compliance actions (e.g. court action) towards those complaints that pose a higher health and safety risk.

When we receive a complaint we may identify other advertisers with the same advertisement. Where this occurs we create a separate case for each additional advertiser. This accounts for the difference between the number of complaints received and the number of cases created.

We completed more than 750 advertising complaint cases

We publish all advertising complaint outcomes on our website in a searchable portal. We received a total of 595 complaints between 1 July 2018, when we assumed sole responsibility for advertising complaints, and 31 December 2018. From these complaints we generated 1,039 cases for action, which were categorised as low (727 cases), medium (301 cases), high (2 cases) or critical risk (9 cases).

At 31 December we had completed 780 cases: 692 low, 47 medium, 1 high, and 5 critical. We resolved these cases by issuing Obligations Letters, Warning Letters, or Directions Notices (i.e. a notice that directs an advertiser to correct or stop non-compliant advertising). Medium, high and critical cases are only closed when we are satisfied that the identified breaches have been addressed.

We continue to work towards resolution of the remaining open complaint cases.

We are using new enforcement powers to protect consumers

Amendments to the therapeutic goods legislation in March 2018 introduced enhanced sanctions and penalties for breaches of advertising regulations. We use these new powers to take action against non-compliant advertisers.

In September 2018 Gumby Gumby Australia complied with our direction to stop advertising unapproved medicines, including making claims that these medicines may have an effect on cancer and other serious conditions and in December 2018 we initiated court action against Peptide Clinics Australia for allegedly advertising prescription-only medicines and other alleged advertising breaches. This month, January 2019, we issued a direction to Evolution Supplements to stop advertising prescription-only and unapproved medicines.

Looking ahead

We have a busy time ahead in therapeutic goods advertising regulation. Our advertising team is expanding to make sure we are able to meet demand, including appointment of more staff with the expertise to conduct reviews of the evidence held by advertisers for their claims.

We will be making significant improvements to the information available on our website through the complaint outcomes portal. This includes more information about each case and the reasoning for our findings, improved filtering and search functionality, and a more user friendly lay-out.

The resolution of advertising complaints will continue to be a priority, as will the establishment of the assurance function for the review of some closed cases.

Education for both advertisers and consumers will also remain important. We have more training events and educational resources planned, including the publication of more questions and answers to help advertisers comply with the Code.

As always, our overarching goal will be ensuring accurate and socially responsible advertising of therapeutics goods in Australia. We will continue to assess and refine our ways of working in service of this goal.

For more information about therapeutic goods advertising regulation, including our contact details, visit the advertising hub.