Stephens Lawyers & Consultants
Companies involved in the supply of therapeutic goods in Australia must ensure that their advertising complies with the requirements of the Therapeutic Goods Act 1989 (Cth), the Therapeutic Goods Advertising Code (Advertising Code) and the Australian Consumer Law. The advertising and promotion of prescription-only medicines directly to consumers, including through company social media accounts, by social media influencers and online advertisers, is prohibited under the Therapeutic Goods Act and Advertising Code.
The Therapeutic Goods Administration (TGA), the regulator responsible for administration of the laws, has been stepping up its enforcement actions to stop unlawful advertising to the public of therapeutic goods including prescription-only medicines.
Businesses and individuals involved in unlawful advertising of therapeutic goods, expose themselves to TGA infringement notices imposing significant fines and possible court proceedings being brought by the TGA that can lead to imposition of penalties for contravention of the law. Advertising prescription-only medicines to the public can result in criminal and civil penalties for both corporations and individuals amounting to many millions of dollars.[i]
Advertising for ‘off label use’
The TGA has also been targeting businesses who have been involved in unlawful advertising of prescription-only medicines for “off label use”, that has not been approved by the TGA. For example, Ozempic has been approved by the TGA and is included in the Australian Register of Therapeutic Goods (ARTG) for the treatment of type 2 diabetes. Ozempic, as a prescription only medicine cannot be advertised for treatment of type 2 diabetes or for “off label use” for weight loss treatment.[ii]
It is also a contravention of the Therapeutic Goods Act to advertise a medicine which has been included in the ARTG for the treatment of a specific indication or condition, for some other “off label use” of that medicine.
The laws governing the advertising of therapeutic goods are complex. The courts have ruled that businesses and individuals involved in the manufacture, supply or advertising of therapeutic goods including prescription-only medicines, pharmacy medicines and health/sport supplements advertised for therapeutic use, must be aware of and understand their legal obligations under the Therapeutic Goods Act, the Advertising Code and the Australian Consumer Law – and must comply with them. Ignorance of the law is no defence to a prosecution for breach.
Recent TGA Enforcement Actions
The TGA has been stepping up its enforcement actions to stop unlawful advertising to the public of therapeutic goods and medicines – such as Ozempic and medicinal cannabis, which are prescription-only medicines and cannot be advertised to consumers.
$18,780 fine issued for alleged unlawful advertising of Ozempic
On 30 May 2024, the TGA issued an infringement notice and fine for AU$18,780 to Myers Pharmacy Pty Ltd for its alleged unlawful advertising of the prescription-only medicine, Ozempic, through in-store signs at a Western Sydney pharmacy.[iii]
TGA issues 11 infringement notices for alleged unlawful advertising of Medicinal Cannabis
On 23 May 2024, the TGA issued a total of 11 infringement notices to Better Leaf Pty Ltd (the Company) for alleged unlawful advertising of medicinal cannabis, a prescription-only medicine, on its website and social media platforms. The notices were comprised of:
- 9 infringement notices issued to the Company, totalling AU$164,460; and
- 2 infringement notices totalling AU$7,512 issued to an individual.
The TGA alleged that, in this case, the advertisements promoted the use or supply of medicinal cannabis as well as making ‘restricted representations’ to the treatment of serious diseases and conditions such as post-traumatic stress disorder and epilepsy, without TGA permission or approval.[iv] Restricted representations cannot be used in advertising of medicines and therapeutic goods without prior approval or permission from the TGA with the exception of restricted representations that are legally required to be included on the product label.[v]
Key takeaways – Risk Management
The complex legal framework that regulates the advertising of health services, therapeutic goods and pharmaceutical products in Australia exposes businesses, advertisers and individuals to the risk of contravening the Therapeutic Goods Act, the Therapeutic Goods Advertising Code and other applicable advertising laws, the risk of incurring significant penalties – as well as a risk of reputational and ‘brand’ damage. [To read our article on ‘Advertising of Health Services – New Advertising Guidelines’ see HERE – AND – To read our article on ’Advertising of Therapeutic Goods in Australia – Are your advertising campaigns compliant?’ see HERE]
Some of the strategies that businesses and advertisers could implement to minimize the risk of non-compliance include:
- Education and training of personnel involved in the supply, marketing and advertising of therapeutic goods, including medicines, health/sports supplements and medical devices of the legal framework for advertising and marketing;
- Review of all existing advertising including website and social media for compliance by legal experts.
- Review of proposed advertising by legal experts before it is published.
- Insurance cover.
Disclaimer: This article is not intended to be a substitute for obtaining legal advice.
© Stephens Lawyers & Consultants. 25 June 2024; Authored by Katarina Klaric, Principal, and Rochina Iannella, Lawyer, Stephens Lawyers & Consultants
For further information contact:
Katarina Klaric
Principal
Stephens Lawyers & Consultants
Melbourne Head Office
Suite 205, 546 Collins Street, Melbourne VIC 3000
Phone: (03) 8636 9100
Sydney Office
Level 29, Chifley Tower, 2 Chifley Square, Sydney, N.S.W. 2000
Phone: (02) 9238 8028
Email: [email protected]
Website: www.stephens.com.au
All Correspondence to:
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[i] Therapeutic Goods Act (Cth) 1989 – Division 3A (Advertising offences and civil penalties) – Secs 42DL to 42DMA ;
[ii] Therapeutic Goods Administration: Australian Government Department of Health and Aged Care Website: ‘Advertising prescription medicine Ozempic (semaglutide) is prohibited” ; Advertising prescription medicine Ozempic (semaglutide) is prohibited | Therapeutic Goods Administration (TGA) (Accessed 4 June 2024)
[iii] Therapeutic Goods Administration: Australian Government Department of Health and Aged Care – Media Release: “Myers Pharmacy fined for alleged unlawful advertising of Ozempic”, Published 30 May 2024 – https://www.tga.gov.au/news/media-releases/myers-pharmacy-fined-alleged-unlawful-advertising-ozempic
[iv] Therapeutic Goods Administration: Australian Government Department of Health and Aged Care – Media Release: “Better Leaf Pty Ltd fined for alleged unlawful advertising of medicinal cannabis”, Published 23 May 2024 – https://www.tga.gov.au/news/media-releases/better-leaf-pty-ltd-fined-alleged-unlawful-advertising-medicinal-cannabis
[v] Ibid.