From 1 January 2019, businesses marketing and advertising therapeutic goods (medicines and medical devices) must comply with new requirements under the Therapeutic Goods Advertising Code 2018 (2018 Code).
In addition to general requirements under the Australian Consumer Law with respect to false, misleading and deceptive claims, the 2018 Code specifically regulates the types and content of representations that can be made about therapeutic goods. Notably, this includes everyday items such as sunscreen.
Key changes under the 2018 Code include:
- definitions – a broader definition of “advertise” which captures any materials intended to promote the use or supply of therapeutic goods;
- paragraph 4 – inclusion of a new provision requiring health warnings to be included on labels or instructions for use if the therapeutic good may lead to death, hospitalisation, or require treatment from a medical practitioner for injury, disability, incapacity or impairment;
- paragraph 9 – clarification of the definition of “accuracy”, requiring any advertisement to be consistent with the therapeutic good’s entry on the Australian Register of Therapeutic Goods;
- paragraph 12 – clarification of the difference between “direct” and “internet” marketing, where the latter concerns goods that are not available for physical examination by the consumer prior to purchase, and what information must be included for this type of marketing;
- paragraph 17 – clarification of the requirements for using testimonials in therapeutic good advertisements, including disclosure where valuable consideration has been provided to the person giving the testimonial or where the person is a relative or associate of an individual who is involved with the production, sale or supply of the good;
- paragraph 19 – clarification of the prohibition on advertising therapeutic goods to children, where advertising must not be “primarily directed” at children under the age of 12 years;
- paragraph 23 – inclusion of a new provision that requires advertisements for complementary medicines (i.e. ‘traditional’ or ‘alternative’ medicines) to disclose any claim based on evidence of a history of traditional use;
- paragraph 27 – inclusion of a new provision that sets out the requirements for advertising sunscreens; and
- paragraphs 28 – 30 – streamlining of the provisions and appendices that govern prohibited and restricted representations made about therapeutic goods i.e. claims about treatment of serious diseases.
The Therapeutic Goods Administration is encouraging businesses to ensure their advertising and marketing practices are compliant well in advance of the 2018 Code becoming effective. Further information on the transition and educational materials can be found at this link.