Therapeutic goods advertising in Australia: the Code and the no-go zones

What the regime is

The supply and advertising of therapeutic goods in Australia is governed by the Therapeutic Goods Act 1989. This Act covers a broad range of products, including medicines, medical devices, and biologicals.

The Therapeutic Goods Administration (TGA) administers the Act. The TGA’s role includes overseeing compliance with the law and related regulations.

Detailed advertising rules are set out in the Therapeutic Goods Advertising Code. Advertising that does not adhere to the Code may also be considered a breach of the Therapeutic Goods Act 1989.

What cannot be advertised to consumers

Advertising of certain therapeutic goods to consumers is strictly limited in Australia. Direct-to-consumer advertising of prescription medicines (Schedule 4) and Schedule 8 controlled drugs is essentially prohibited. Similarly, advertising of pharmacist-only medicines (Schedule 3) is generally not permitted.

There are limited exceptions to the restrictions on advertising pharmacist-only medicines. Some products listed in Appendix H are permitted to be advertised to consumers.

Certain representations about therapeutic goods require pre-approval before they can be made. These restricted representations include claims relating to cancer, sexually transmitted infections, and some serious diseases.

Code requirements for advertising that IS allowed

Advertising for therapeutic goods in Australia is permitted, but subject to strict conditions. All claims made in advertising must be accurate, balanced, and not misleading. This means that any information presented about a therapeutic good’s benefits, risks, or performance must be truthful and provide a complete picture.

Advertising that includes testimonials requires specific considerations. Testimonials must be genuine reflections of a person’s experience with the product. They must directly relate to the advertised product and any payment or other material connection between the person giving the testimonial and the company advertising the product must be clearly disclosed.

Comparisons between therapeutic goods are allowed, but must adhere to stringent requirements. Any comparisons made must be fair, complete, and capable of being substantiated with evidence. Advertising must also include mandatory statements, such as advising consumers to read the label and follow directions for use.

Penalties and enforcement

The Therapeutic Goods Administration (TGA) has several avenues for addressing breaches of the advertising code. These include issuing infringement notices, accepting enforceable undertakings to rectify non-compliance, suspending or cancelling sponsor registration, and pursuing civil penalties through the Federal Court. penalty estimator

Significant financial penalties can be imposed for non-compliance. Corporate bodies face the prospect of substantial civil penalties for serious or repeated contraventions of the advertising code. The Act also provides for criminal penalties for the most serious offences, such as advertising prescription medicines directly to consumers or making representations about therapeutic goods that have not been approved.

• Advertising prescription medicines to consumers
• Making prohibited representations without approval

These criminal offences carry the potential for serious consequences.