Australia's new Therapeutic Goods Advertising Code effective 1 January 2019

By Lynne Lewis, Katrina Dang

12-2018

The past year has seen several key changes to the regulatory framework governing the advertising of therapeutic goods (medicines and devices) in response to the Sansom Review. Among these reforms is the introduction of a new Therapeutic Goods Advertising Code (New Code) which will come into effect on 1 January 2019 to clarify and simplify advertising requirements for therapeutic goods.

The key changes in the New Code include:

  • Advertising to children. The New Code clarifies the restrictions surrounding advertising of therapeutic goods to children. It defines a child as any person under the age of 18 and stipulates that therapeutic goods must not (other than for limited exceptions) be directly advertised to any child under the age of 12 years. Schedule 2 of the New Code lists goods which may be advertised to children 12 years or over.
  • Testimonials. The current regulation of testimonials is expanded to require advertisers to verify the accuracy and genuineness of a testimonial. Advertiser must also disclose whether the person providing the testimonial has received any valuable consideration or if they are in any way affiliated with the advertiser.
  • Endorsements. Advertisers cannot include any reference to the sponsorship of any government agency, hospital or other facility providing healthcare in their advertisements. The list of people prohibited from providing endorsements has expanded to include employees or contractors of a government authority, hospital or healthcare facility.
  • Samples. The New Code only allows condoms, sunscreens, stoma devices for self-management, and continence catheter devices for self-management to be offered as promotional samples.
  • Online advertisements and sales. The New Code prescribes information that must be contained in advertisements for medicines and medical devices which are not available for physical examination before purchase (i.e. sold online).
  • Weight management products. Advertisers of therapeutic goods containing any claim relating to weight management must not include any reference or depiction suggesting that the therapeutic goods will correct or reverse the effects of overeating. Advertisers must not feature images, visual representations, statistics or testimonials of individuals unless they have achieved those results from the use of the goods and the results can also be achieved by the average user of the goods.
  • Sunscreen. Any sunscreen product that claims that it will prevent sunburn or skin cancer must depict sunscreens as being only one part of sun protection and include prominent statements or visual representations stating that prolonged high-risk sun exposure should be avoided and frequent re-application or use in accordance with directions is required for sun protection.

Failure to comply with the New Code is both a civil and criminal offence carrying penalties of up to A$4.2m per offence. Advertisers need to familiarise themselves with the new Code and ensure they comply from 1 January 2019.