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Advertising health services with Schedule 3, Schedule 4 or Schedule 8 medicines
Information for health professionals
Restrictions on advertising therapeutic goods are in place to protect the health and safety of consumers.
Before a therapeutic good containing a Pharmacist Only medicine1, Prescription Only medicine or Controlled Drug (restricted scheduled substance/s) can be prescribed for a particular patient, a health professional needs to assess whether the therapeutic good is appropriate and suitable for that patient. Advertising that encourages consumers to seek out restricted scheduled substances prior to such an assessment may undermine the prescriber-patient relationship, and is prohibited under the Therapeutic Goods Act 1989 (the Act).
An advertisement for a health service that specifies the use of particular therapeutic goods associated with that service, including restricted scheduled substances, would be likely to promote the therapeutic good concerned.
What is the law?
In Australia, advertisements for therapeutic goods must comply with:
- The Act and associated subordinate legislation,
- Health Practitioner Regulation National Law (and applicable advertising guidelines),
- Australian Consumer Law, and
- State and Territory Laws.
The Act prohibits advertising to the general public for a substance or a therapeutic good containing a substance included in Schedule 3 (Pharmacist Only medicine), 4 (Prescription Only medicine) or 8 (Controlled Drug) of the Standard for the Uniform Scheduling of Medicines and Poisons (known as the current Poisons Standard2). Advertisements for therapeutic goods must not refer to a restricted scheduled substance, even where:
- the restricted scheduled substance is one of several ingredients contained in a therapeutic good, including substances that are not restricted scheduled substances; or
- the advertisement does not refer to the restricted scheduled substance by name.
Implied references to either trade names of therapeutic goods containing a restricted scheduled substance or the ingredient name of a restricted scheduled substance (e.g. abbreviations, acronyms) are also unacceptable.
Some limited exceptions apply, including an exception for those Schedule 3 substances listed in Appendix H to the current Poisons Standard which are permitted to be advertised directly to consumers.
When non-compliant advertising comes to the TGA's attention, the advertiser is notified (see Penalties for non-compliance).
How to advertise legally
To comply with the therapeutic goods legislation, advertising should focus on the services that your business provides without referencing restricted scheduled substances.
If you reference specific therapeutic goods (or types of therapeutic goods), that are used in a course of treatment, the information could be considered promotional, and therefore is an advertisement for therapeutic goods within the meaning of the Act. A similar issue arises where health professionals provide information and advice on their websites for patients considering particular types of treatments involving specified therapeutic goods.
Therapeutic goods that do not contain restricted scheduled substances can be advertised to consumers provided that the advertising complies with the requirements under the Act, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods Advertising Code 2015. Under the Act, it is also an offence to advertise a therapeutic good for "off-label" use to any person.
Penalties for non-compliance
In the first instance, the TGA seeks to inform, educate and assist advertisers to comply with the rules relating to advertising. However, if this approach fails, we may take further action to achieve compliance.
The Act provides for financial penalties for advertising breaches. Fines for such offences can be up to $10,800 for individuals and up to $54,000 for corporations3.
- Section 3(1) of the Act - an advertisement, in relation to therapeutic goods, is defined as including "any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods".
- Section 22(5) of the Act - it is an offence to advertise a medicine for an indication that is not included on the Australian Register of Therapeutic Goods (ARTG) entry for the medicine. Section 41ML of the Act provides a similar offence for medical devices.
- Section 42DL(1)(f) of the Act - it is an offence to advertise therapeutic goods with a statement referring to goods, or a substance or preparation containing goods, included in Schedule 3, 4, or 8 of the current Poisons Standard, other than a statement authorised or required by a government or government authority. However, section 42DL(3)(b) of the Act exempts goods, substances and preparations listed in Appendix H of the Poisons Standard from this provision.
- Section 42DM(1) of the Act - it is an offence to publish or broadcast an advertisement to consumers for therapeutic goods that does not comply with the Therapeutic Goods Advertising Code.
- visit ComLaw for:
- the Therapeutic Goods Act 1989
- the Therapeutic Goods Advertising Code 2015
- the Standard for the Uniform Scheduling of Medicines and Poisons
For information relating to the content of advertisements, see Advertising therapeutic goods or consult a regulatory affairs consultant.
For further information about advertising therapeutic goods:
- visit the TGA website
- email TGA.Advertising@tga.gov.au
- contact AHPRA, the ACCC and your State/Territory Health department.
- For the purposes of this information, the term medicine includes both finished products and substance/s. Note that some medical devices can incorporate medicines.
- The Poisons Standard is a legislative instrument prepared by the Secretary (or delegate) under Part 6-3 of the Act.
- These amounts are current as at the date of publication of this fact sheet.