In brief

In light of recent regulatory activity by the Therapeutic Goods Administration (TGA), it is timely to consider the regulatory frameworks that apply to advertising medicines and other therapeutic goods in Australia.

What is considered?

Any ‘advertisements’ of medicines to the public must comply with the Therapeutic Goods Act 1989 (Cth) (TG Act), the Therapeutic Goods Regulations 1990 (Cth) (TG Regulations) and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth) (Advertising Code).

Under the TG Act, ‘advertising’ is very broadly defined as ‘any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods’.

The test for whether material is an ‘advertisement’ for therapeutic goods is an objective one. The relevant question is “would a consumer be likely to consider the statement, pictorial representation or design to be promoting the use or supply of the medicine?” All elements of an advertisement are considered – for example, a company logo which depicts a cannabis leaf may be considered as advertising medicinal cannabis (an unapproved and prescription only medicine) and is therefore prohibited (see Part 3). A picture of the medicinal cannabis product next to an article that would (without the image) not be regarded as advertising, may change the position so that, taken together, the article and the picture comprise an advertisement.

Importantly, the therapeutic goods laws prohibit advertising certain medicines. Prescription medicines, some Schedule 3 (pharmacist only) medicines and medicines that have not been approved by the TGA and registered or listed in the Australian Register of Therapeutic Goods (ARTG) must not be advertised to the public. Advertisements directed exclusively to health practitioners are not bound by the Advertising Code (however strict rules apply to where such advertisements can be placed to limit access to them).

The laws apply to advertisements on all forms of verbal, printed or electronic media including traditional media (e.g. TV, radio, newspapers), electronic media (including social media) and any other material presented to the public (e.g. billboards, workshops, podcasts and shopfronts) but does not apply to genuine news articles.

What is required?

Advertisements must not contain “prohibited representations”. Prohibited representations are any references to certain serious diseases or illnesses including cancer, sexually transmitted diseases (including HIV) and mental illnesses.

Other representations for medicines used in treating diseases or illnesses that usually require diagnosis by a medical or healthcare professional are known as ‘restricted representations’ and must be approved by the TGA before being used in advertisements. The advertisements must then comply with the wording approved by the TGA.

Under the therapeutic goods advertising laws, companies should ensure that any advertisements to consumers for pharmacy-only (Schedule 2) or permitted Schedule 3 medicines comply with the TG Code and:

• are accurate and balanced;
• do not represent that the medicine is safe, without harm or side effects, effective or a guaranteed cure, or infallible, magical or miraculous;
• do not cause, or be likely to cause, undue alarm, fear or distress;
• minimise misuse of their products and promote safe usage;
• are not misleading to the consumer about the nature or performance of the product;
• support informed healthcare choices;
• only contain information that is able to be substantiated;
• are consistent with listed indications / intended purposes for the goods (as specified in the ARTG, if applicable);
• do not exaggerate efficacy and encourage excessive use;
• include any mandatory statements required by the therapeutic goods laws;
• include warnings where specific ingredients are present;
• only contain easily understood scientific or clinical terminology;
• comply with therapeutic goods laws as to restricted and prohibited representations (see above);
• must not be directed to children under 12 years old;
• only contain compliant testimonials and endorsements; and
• must not be inconsistent with current public health campaigns.

TGA enforcement powers

The TGA has broad powers to investigate potential breaches of the TG Act. Under section 45AB of the TG Act, the TGA may require a person to provide requested information and/or produce requested documents. The potential for self-incrimination does not excuse an individual from giving information or producing a document under section 45B of the TG Act. This investigative power is in addition to the TGA’s entry, search and seizure powers.

The requirements for advertising medicines can be complex. The TGA will often reach out to companies to let them know when they consider that the company’s advertising may be in breach of the laws and provide an opportunity to take corrective action. Infringement notices may be issued by the TGA where companies do not respond appropriately to its requests for them to remove or alter advertising materials. For more serious or repeated contraventions of the therapeutic goods advertising laws, the TGA can commence proceedings against companies and individuals.

For businesses that are also considered to be advertising ‘regulated health services’, it is also necessary to consider the advertising requirements of section 133 of the Health Practitioner Regulation National Law (enacted in each state and territory) – see AHPRA’s Guidelines for advertising a regulated health service. Health practitioners registered under the National Law must comply with the requirements of section 133 and comply with the codes and guidelines published by their relevant National Boards.