Legal Framework Governing Advertising of Therapeutic Goods in Australia

1. Primary Legislation: Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (the Act) provides the main legislative basis for regulating therapeutic goods, including their advertising. Part 2-2 of the Act prohibits false or misleading advertising of therapeutic goods, while specific provisions in sections 22, 42DL, 42DM and others address advertising offences, restricted representations, and prohibited claims. The Act empowers the making of instruments such as the Advertising Code. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework

2. Key Subordinate Legislation: Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021

The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code) is the primary subordinate instrument setting detailed standards for advertising therapeutic goods. It applies to advertisements directed to consumers and health professionals, requiring claims to be truthful, balanced, substantiated by evidence, and presented in a manner that does not mislead or create undue fear. The Code includes requirements for clear disclosure, appropriate language, and restrictions on certain representations (e.g., serious diseases). Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework

3. Additional Relevant Instruments and Regulations

• Therapeutic Goods (Therapeutic Goods Advertising Code – Consequence) Instrument 2021: Specifies consequences for non-compliance with the Code.
• Therapeutic Goods Regulations 1990: Contains provisions related to advertising, including definitions and exemptions.
• Therapeutic Goods (Excluded Goods) Determination: May affect whether certain products fall under advertising rules. These instruments complement the Act and Code to form the complete advertising legal framework. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework

4. Application to Different Product Categories

The legal requirements vary depending on the type of therapeutic good:

• Registered medicines (AUST R): Generally cannot be advertised directly to consumers; advertising is restricted to health professionals.
• Listed medicines (AUST L): May be advertised to consumers, but claims are limited to those permitted under the Code and must comply with evidence requirements.
• Medical devices: Subject to specific advertising restrictions, particularly for higher-risk classes.
• Biologicals and other categories: Have tailored rules reflecting their risk profile. Non-compliance with category-specific rules can result in breaches of the Act. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework

5. Enforcement and Penalties

The TGA enforces the advertising framework through monitoring, investigations, and actions ranging from advisory letters to civil penalties, infringement notices, and court proceedings. Serious or repeated breaches may lead to criminal penalties under the Act. The TGA publishes enforcement outcomes to promote transparency and deterrence. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework

6. Practical Implications for Advertisers

Advertisers must ensure all promotional materials comply with the Act, the Code, and relevant instruments. This includes substantiating claims, avoiding prohibited or restricted representations, and tailoring content to the intended audience. Non-compliance can result in significant legal and reputational consequences. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework

7. Related Guidance and Resources

The TGA provides extensive guidance on interpreting and applying the advertising framework, including specific documents on the Advertising Code, restricted representations, and enforcement policies. Advertisers are encouraged to consult these resources and, where necessary, seek advice from the TGA. Source: https://www.tga.gov.au/products/regulations-all-products/advertising/advertising-legal-framework