Therapeutic goods are intended to have a therapeutic effect and influence the health status of the people that use them. Many of these people will be vulnerable because of the disease or condition that they are facing or because of a general concern about their health.
The advertising of therapeutic goods is subject to the requirements of the Therapeutic Goods Act 1989 (the Act), Therapeutic Goods Regulations 1990 (the Regulations) the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code).
These requirements aim to ensure advertisements are socially responsible and do not mislead or deceive the public.
For a more detailed list of therapeutic goods legislation, see Legislation and legislative instruments.
Therapeutic Goods Act 1989
We administer the Commonwealth therapeutic goods legislation to regulate the advertising of therapeutic goods in Australia through the requirements set out in the Therapeutic Goods Act 1989.
The Act sets out the legal requirements for the import, export, manufacture, supply and advertising of therapeutic goods in Australia.
In relation to advertising, the Act:
- provides criminal offences and civil penalties to prohibit certain types of therapeutic goods from being advertised to the public.
- contains requirements that advertisers must meet when advertising therapeutic goods to the public, including the requirement to comply with the Therapeutic Goods Advertising Code.
- provides for a range of compliance and enforcement tools that the TGA may use to address non-compliant advertising. For more information see, Compliance management.
The majority of these legislative requirements relate to advertising to the public with only a few requirements for advertising to health professionals.
The Act prohibits advertising therapeutic goods to the public in circumstances where the advertisement:
- contains a prohibited representation unless a permission is in place.
- contains a restricted representation, unless an approval or permission is in place
- does not contain a required representation.
- contains a reference to the Act, other than in a statement of the Australian registration, listing or device number for the goods
- suggests or implies that the goods have been endorsed or approved by a government authority, including a foreign government authority. For more information see The claim 'TGA approved' must not be used in advertising.
- refers to substances, or goods containing substances, included in Schedule 3 (Pharmacist Only), 4 (prescription only medicine) or 8 (controlled drugs) to the Poisons Standard (but not in Appendix H), unless authorised or required.
- refers to a biological (a product of the body, such as blood or cells) unless authorised or required.
- refers to therapeutic goods that are not entered in the Australian Register of Therapeutic Goods (ARTG), and that are prescribed in the Regulations.
For information about how to assess whether materials and activities are advertisements for therapeutic goods and therefore subject to the Act’s requirements see Understanding activities that represent advertising.
The requirements for advertising to the public do not apply to:
- advertising directed exclusively to specified health professionals and other people engaged as purchasing officers for these health professionals. For more information see: Advertising to health professionals so that consumer rules do not apply.
- information shared between a health practitioner and their patient during consultation or treatment, even where such information is promotional.
The Act also provides that it is an offence to advertise therapeutic goods for an indication or purpose that is not included in the ARTG entry for the goods. This prohibition also applies to advertising directed exclusively to healthcare professionals.
Therapeutic Goods Regulations 1990
The Therapeutic Goods Regulations 1990 prescribe in further detail specific matters required or permitted by the Act. Examples include:
- definitions and details of prohibited and required representations
- prescribed goods for certain advertising offences and penalties, for example specifying the types of unapproved therapeutic goods that are not permitted to be advertised to the public
- details the types of products that are required to be listed or registered in the ARTG
- details the types of products that are exempt from the requirement to be entered in the ARTG.
Therapeutic Goods Advertising Code
The Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 establishes the standards for advertising therapeutic goods to the public.
The Code is a legislative instrument was made under section 42BAA of the Act. There are criminal offences and civil penalties for advertising to the public in a manner that does not comply with the Code.
Advertising of therapeutic goods requires a higher ethical standard than may apply for advertising of ordinary consumer goods because consumers rely on therapeutic goods for their health.
It can be difficult for a consumer to determine the appropriateness of a therapeutic good for their particular circumstances.
The Code contains provisions to ensure that advertisements promote the safe and proper use of therapeutic goods, is ethical, does not mislead or deceive consumers, are not inconsistent with public health campaigns and support informed health care choices.
Other legislation
The Competition and Consumer Act 2010, administered by the Australian Competition and Consumer Commission (ACCC), as well as associated state and territory laws, protects consumers from false or misleading advertising of products and services. These laws apply to therapeutic goods in addition to the Act and the Code administered by us.
Other Commonwealth, state, and territory legislation may apply to certain medicines. The scheduling of substances in the Poisons Standard and the safe storage and transport of therapeutic goods (e.g. by wholesalers) are also covered by state or territory legislation.
Industry self-regulation
Industry organisations that represent various therapeutic goods sectors generally have a code of practice for members that includes advertising requirements and compliance arrangements.
Industry associations are generally responsible for advertising directed to health professionals.