On 7 May 2021, the Therapeutic Goods Administration (TGA) released a consultation paper (the Paper) regarding proposed improvements to the Therapeutic Goods Advertising Code (the Code).
These proposals are generally intended to minimise compliance costs, ensure that provisions of the Code function as intended and improve understanding and compliance by advertisers. Public submissions can be made in respect of the Paper until 18 June 2021.
The TGA has proposed amendments to improve the clarity and interpretations of provisions of the Code that have been identified as being unclear, inconsistent or otherwise difficult to work with. Key changes which have been proposed or raised in the Paper include:
- strengthening provisions of the Code to prohibit advertisements from including content that may create fear or distress or lead people to believe that they are, or could, suffer from a serious ailment;
- including mandatory statements on advertisements that are directed at health professionals but may be accessed by the public to ensure that consumers are aware that the relevant products are available for purchase by health professionals only;
- amending the content of mandatory health warning statements where advertisements are genuinely limited by physical space or character count;
- clarifying when health warnings are required (for instance, the Code as currently drafted can lead to situations where warnings for some non-prescription medicines are required in advertising but not on a product’s label, such as where ingredients are only present in trace or very small amounts);
- amending the regulation of endorsements and testimonials, such as:
- introducing a new clause to prohibit endorsements by former health professionals whose name and reputation may continue to carry significant weight;
- permitting testimonials from those involved in the direct sale or marketing of therapeutic goods to the public (provided that any perceived conflict of interest is adequately disclosed to consumers); and
- ensuring that testimonial disclosure requirements are clearly expressed, consistent and adequate to protect consumers;
- clarifying provisions to make it clear that both the offer and provision of free samples in conjunction with advertising of therapeutic goods are prohibited; and
- introducing further requirements for:
- representations which are “restricted representations” (ie. representations concerning diseases or conditions that require diagnosis, treatment or supervision by a healthcare professional);
- “prohibited representations” (eg. representations regarding mental illness) and scientific; and
- scientific or clinical representations.
We will provide further information about the possible amendments to the regulation of testimonials and endorsements in a separate Insight.
A copy of the Paper can be accessed here. For more information regarding the proposed amendments to the Code, or the regulation of therapeutic goods generally, please contact a member of the Addisons team.
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