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Advertising health services with medical devices
Information for health professionals and health practitioners
Restrictions on advertising therapeutic goods are in place to protect the health and safety of consumers.
An advertisement to the general public for a health service that specifies (whether directly or indirectly) the use of a therapeutic good or goods, including medical devices, would be likely to promote the therapeutic goods concerned. Medical devices include within its scope in vitro diagnostic medical devices (IVDs). Such health service advertisements must therefore comply with the Australian therapeutic goods advertising legislation. There are some provisions of the therapeutic goods advertising legislation that also apply to advertising to health professionals.
What is the law?
In Australia, advertisements for therapeutic goods must comply with:
- The relevant provisions in the Therapeutic Goods Act 1989 and associated subordinate legislation (collectively the therapeutic goods advertising legislation),
- Health Practitioner Regulation National Law relating to applicable advertising guidelines,
- The Competition and Consumer Act 2010 (incorporating the Australian Consumer Law), and
- State and Territory advertising requirements in relation to therapeutic goods.
The therapeutic goods advertising legislation
Under the Therapeutic Goods Act 1989 (the Act), it is prohibited and is an offence to:
- advertise to any person a medical device that is not included on the Australian Register of Therapeutic Goods (ARTG);
- advertise to any person a medical device for purposes other than the manufacturer's intended purpose (i.e. 'off-label' use);
- to advertise a medical device to the general public that:
- includes a reference to a serious form of a disease, condition, ailment or defect without prior TGA approval;
- includes a statement or implication that the goods have been recommended or approved by a government authority e.g. Therapeutic Goods Administration, Food and Drug Administration; or
- is an advertisement that does not comply with the Therapeutic Goods Advertising Code 2015 (the Code).
The Code sets out a number of requirements, including that an advertisement about therapeutic goods that is directed to the public;
- must contain only correct and balanced statements that have been substantiated;
- must not mislead or be likely to mislead;
- must not arouse unrealistic expectations of product effectiveness;
- must not lead a person to believe that they are suffering from a serious ailment;
- must not claim that the good is guaranteed, certain cure or that the goods are completely safe, harmless or free of side-effects;
- must not imply or contain a health professional endorsement; and
- any testimonials included in the advertisement must be documented, genuine, represent typical cases only and comply with all other aspects of the Code (including the requirement that it must not mislead).
The Act also 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 Standard1). Some medical devices include such substances and therefore cannot be advertised to the general public. See Advertising health services with Schedule 3, Schedule 4 or Schedule 8 medicines for more information.
When non-compliant advertising comes to the TGA's attention, the advertiser is notified of the contravention (see Penalties for non-compliance).
- The Poisons Standard is a legislative instrument prepared by the Secretary (or delegate) under Part 6-3 of the Act.
How to advertise medical devices in compliance with the requirements under the Act and the Code
Where a sponsor of the medical device or an advertiser wishes to advertise medical devices (whether directly or indirectly) to the public, the TGA recommends that they:
- check that the medical device is included in the ARTG - this can be done by obtaining the ARTG inclusion number from the device supplier and/or sponsor;
- confirm the ARTG entry for the medical device, in particular the Intended Purpose and the manufacturer identified on the ARTG entry - this can be done through the TGA's website;
- ensure that all advertising is consistent with the Intended Purpose set out on the ARTG entry, the manufacturer's instructions for use and the product label; and
- ensure that all advertising complies with the requirements under the Act, the Regulations and the Code, including having data to substantiate the advertising claims made.
If you are unable to obtain an ARTG number for the medical device, it may be a therapeutic good that is unlawfully supplied and should be reported to the TGA via the Report a perceived breach or questionable practice section of the TGA website.
If you reference therapeutic goods (or types of therapeutic goods) - whether directly or indirectly - 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.
If you are intending to advertise a medical device to the public, you should assure yourself that the claims you intend to make are supported by data (i.e. the claims will be accurate), balanced and won't mislead. Otherwise, the claims are likely to breach the Act, the Code and the Competition and Consumer Act 2010.
If you are concerned about the compliance of your health services advertisement with the therapeutic goods advertising legislation, your advertising should focus only on the health services that your business provides without referencing (directly or indirectly) the particular medical device(s) involved. However, please note that the advertising (and associated services) will still need to comply with all other relevant legislative requirements (including the Health Practitioner Regulation National Law and the Competition and Consumer Act 2010).
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 corporations2.
- These amounts are current as at the date of publication of this fact sheet.
- Subsection 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'.
- Subsection 41BD(1) of the Act - a medical device is defined as any instrument, apparatus, material or other article (whether used alone or in combination, and including the software necessary for its proper application) that is intended by the person in whose name it is or is to be supplied, to be used for human beings for specific therapeutic purposes set out in this section of the Act (e.g. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap). The definition includes in vitro diagnostic medical devices. Other instruments, apparatus, appliance, material or other article can be specified by the Secretary of the Department of Health through a notice in the Government Gazette or TGA website, or by legislative instrument. Similarly, the Secretary can declare that particular instruments, apparatus, appliance, material or other article are not medical devices through an order published in the Government Gazette or TGA website.
- Section 41ML of the Act - it is an offence to advertise a medical device for a purpose not accepted in relation to the device's inclusion in the ARTG. The corresponding civil penalty provision is set out in section 41MLA. Section 22(5) provides a similar offence for medicines.
- Section 41MI of the Act - it is an offence to supply a medical device in Australia that is not included in the ARTG (Section 3 defines 'supply' to including advertising). The corresponding civil penalty provision is set out in section 41MIB. Further, under section 41MM of the Act, it is an offence to claim to be able to supply a medical device not included in the ARTG or exempt from inclusion. Section 19B of the Act provides a similar offence for medicines.
- Paragraph 42DL(1)(f) of the Act - it is an offence to publish or broadcast an advertisement for therapeutic goods that contains 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, paragraph 42DL(3)(b) of the Act exempts goods, substances and preparations listed in Appendix H of the Poisons Standard from this prohibition.
- Paragraph 42DL(1)(g) of the Act - it is an offence to advertise a therapeutic good that is not entered in the ARTG and the goods are not the subject of an exemption from the requirement for inclusion in the ARTG.
- Subsection 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: