Future direction

As we look ahead, there will be ongoing opportunities to refine and strengthen the therapeutic goods advertising framework and the TGA's role as a responsive regulator. Collaboration with all our stakeholders is an important aspect of this process as we work to ensure the safety, health and wellbeing of all Australians.

We will be working to build our data set and reporting functions to better support us in identifying trends in non-compliance and tailoring education and assurance activities. This will include continuing education and assurance efforts, developing and refining educational material to ensure it has the most effective regulatory impact, and improving our ability to identify targets for sector-specific assurance activities.

In addition, the TGA will continue to deliver new and updated guidance material, including guidance needed to support advertisers through any future legislative changes (e.g. in the event of an update to the Code), as well as respond to trends in non-compliance. Additional educational and guidance work will also be required to ensure advertisers are prepared for the removal of the pre-approval process on 1 July 2020 (see Extension of pre-approval process for more information).

We recognise the many challenges faced by advertisers in an increasingly digital environment. A key area of focus for us will be improving the guidance available to advertisers on applying the Code to online testimonials and paid social media influencers. We are collaborating with Committee members to ensure marketers in this space have an understanding of the legislative requirements for advertising therapeutic goods, and how it is most appropriately applied specifically in relation to digital and social media platforms.

We will continue to handle complaints about advertising of therapeutic goods in accordance with our risk-based activity model, described in the complaints handling framework. This ensures that the matters representing the greatest health and safety risk to Australian consumers receive timely and effective attention.

However, the number of complaints received in the first year of the new framework's operation has exceeded expectations. This may in part be due to the simplification and streamlining of the complaints process, as well as the escalating impact of online and direct marketing. The higher numbers of complaints will necessarily inform the kinds of strategies we may employ to strengthen and refine the framework. Any refinements or other changes to our complaints handling policies will be subject to consultation, in particular with the Committee.

The analysis we conducted on breaches of the 2015 Code and the Code highlights that we have found many allegations that advertising claims are unsubstantiated, to be correct. This is consistently observed across all categories of therapeutic goods. Advertisers must be mindful that appropriate evidence is required to satisfy a number of Code requirements. Detailed information about the levels and types of evidence required to be held by the advertiser in order to meet their regulatory obligations is in the Code guidance material - see Accuracy.

In relation to listed medicines and therapeutic claims, the newly implemented permitted indications provide transparency on what indications are suitable for listed medicines. The transition to permitted indications is expected to help improve protections for consumers from misleading and inappropriate claims about listed medicines. The TGA anticipates that the implementation of permitted indications will lead to improved compliance by advertisers.

Advertising compliance is an integral component of the TGA's broader compliance functions (see the TGA's Regulatory compliance framework on our website. In this context, there are many opportunities to further develop and refine the use of our enforcement powers, which enable us to prosecute offenders whose advertising and compliance attitude puts the Australian public at a high risk of harm. This will serve to set examples in line with the practices of other regulatory bodies, and improve advertiser compliance attitudes.