Advertising therapeutic goods 101: where to start?

Don’t rush – therapeutic goods advertising needs extra care

Under Australian Consumer Law (ACL), advertising for goods or services must not be false or misleading. For therapeutic goods advertising, there are additional and very specific legal requirements that must be met. These are set out in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Advertising Code (the Code). The Therapeutic Goods Administration (TGA) is responsible for ensuring advertisers comply with these rules.   Seeside Advisory recommends you allow additional time in your marketing schedules so that therapeutic goods advertising can be checked for compliance with the Act and the Code.

Establish the type of therapeutic good you want to advertise

Before advertising, clearly identify the type of therapeutic good involved. There are two key reasons for doing this:

• You need to ensure it is not a type of therapeutic good that is prohibited from being advertised to consumers. Therapeutic goods that cannot be advertised to consumers include:
• Prescription Only medicines (except as part of an advertisement for vaccines/vaccination services and pharmacy prescription price lists)
• Controlled drugs (like opioids)
• biologicals (cell and tissue based products)
• most Pharmacist Only medicines
• unapproved therapeutic goods, such as medicinal cannabis and medicines and medical devices that are experimental
• The type of therapeutic good (Pharmacist Only medicine, other medicine, medical device or ‘other therapeutic good’) you want to advertise will determine the key information you must include in the advertisement.

You can generally work out the type of therapeutic good by asking the supplier or looking it up the Australian Register of Therapeutic Goods (select the option to read the summary PDF).

Familiarise yourself with the advertising requirements

The TGA provides a range of information and tools to assist with understanding the therapeutic goods advertising requirements and complying with the Act and the Code.

Some of the key issues new advertisers should be aware of include:

• Claims about the screening, diagnosis, treatment, cure or prevention of cancer are banned. There are, however, exemptions for claims about preventing skin cancer through sunscreen use.
• Claims referring to other serious diseases or conditions are ‘restricted representations’ and require approval from the TGA before being used.
• Under both ACL and TGA laws, advertisers must be able to substantiate their advertising claims. This includes claims about the effect of the goods (e.g. relieve hayfever), other features of the goods (e.g. easy to swallow, no artificial colours) and pricing (e.g. recommended retail price versus our price).    
• Endorsements by health professionals, including doctors and pharmacists, are prohibited.
• Most advertisements for therapeutic goods must include certain information to support consumers in making an informed decision about whether the advertised good will be right for them. The information needed is specified in the Code and varies depending on the type of good and the type of advertisement.
• Advertising claims must not be inconsistent with the indications or intended purpose recorded in the Australian Register of Therapeutic Goods for the medicine or medical device. They also must not conflict with the directions or instructions for use.

If you aren’t sure, seek professional advice

If you aren’t sure of type of therapeutic good you want to advertise or you are unsure if the advertising will comply with all the relevant laws, hold off on your advertising until you have sought advice from a lawyer, the TGA or a professional therapeutic goods advertising compliance consultant, like Seeside Advisory.