On 7 March 2024, the Therapeutic Goods Administration (TGA) published revised guidance (the Guidance) on the advertising of health services which involve cosmetic injectables to ensure advertising rules are applied consistently across all industries that deal with therapeutic goods.
Historically, the TGA has allowed indirect references to prescription-only medicines to be referenced in advertisements related to cosmetic health services. This was allowed only in the context of promoting the service and only by using generic non-product specific terms such as ‘dermal filler’, ‘Botox’, and ‘wrinkle reducing injections.’ This is no longer the case.
The Guidance
The Guidance reinforces that since any advertising of therapeutic goods to the public that contain substances included in Schedule 4 (prescription-only medicines) injectables or Schedule 8 (controlled drugs) to the Poisons Standard, is prohibited under sections 42DL and 42DLB of the Therapeutic Goods Act 1989 (the Act).
Since most cosmetic injectables, medicines and medical devices contain prescription-only substances they cannot be advertised to the public either directly or indirectly, or by use of any of the following references:
- a trade name;
- abbreviations or the use of colloquial terms;
- the use of testimonials and claims about the goods;
- the use of before and after photos; or
- the use of price lists.
The TGA also emphasises in the Guidance that prescription-only medicines are high-risk, and patients should be assessed by a health professional before their use. As such, decisions about treatments that involve prescription-only medicines should only be made by a health professional in consultation with each individual patient.
What you should do now
The TGA recommends that businesses advertising health services that may involve a prescription-only substance should only refer to the type of consultation that the service offers. For example, the TGA suggests; ‘our clinic can provide consultations about reducing wrinkles’ or ‘our clinic can provide consultations about increasing the appearance of lip size and volume’.
Practitioners and cosmetic practices should take prompt steps to review all current and historical advertisements, offerings and marketing materials that may exist online including on social media platforms and either remove or make adjustments to ensure compliance with the Guidance.
Non-compliance with the Guidance could afford some of following consequences in line with the TGA Regulatory Compliance Framework:
- educational letters and/or clinic visits;
- warning letters, with recommendations to review your practice processes;
- suspension or cancellation from the Australian Register of Therapeutic Goods (ARTG);
- advertising injunctions and/or directions notices;
- referral to AHPRA and other regulatory agencies;
- financial penalties; or
- civil and/or criminal proceedings.
Common industry practices clarified
On 10 April 2024, the TGA via a webinar presentation clarified industry concerns in relation to the Guidance. To assist with compliance, please find below a high-level summary, noting that the TGA will review all materials on a ‘case-by-case’ basis, at their own discretion.
| Practice prior to TGA Guidance | Lawful/Unlawful | Practice post TGA Guidance |
|---|---|---|
| Photographs of patients before and after procedures which involve prescription-only medicines. | Unlawful | Before and after photographs of procedures which include or refer to the use of prescription-only medicines should not be used to promote these services. Including photographs used to achieve specific patient results. |
| Patient reviews and/or testimonials regarding procedures which involve the use of prescription-only medicines. Including re-sharing reviews which include the same. | Unlawful | Patient reviews and comments (including comments made by third parties), should not contain reference to procedures which involve the use of prescription-only medication. |
| Price lists for treatments which require prescription-only medicines, advertised on social media and/or websites. | Unlawful | All requests for pricing should only be provided privately to patients, and should be discussed by a health professional in consultation. In accordance with section 42AA of the Act, information shared in private between patient and practitioner do not afford the interest of TGA, and is exempt from advertising rules. |
| Advertising photos or videos promoting treatment or procedures which involve prescription-only medications. | Unlawful | Unless the material advertised is considered by a patient as educational in nature, where a reasonable consumer understands that the intention of the content is not to promote the use or supply of a prescription-only medicine, all inferences to a kind of treatment or procedure that involves prescription-only medication should be discussed by a health professional in consultation. |
| Practice/Practitioner trading names which include the direct or indirect inference to a prescription-only medication. | Unlawful | All forms of advertisements, including trading names should not refer, in any capacity, to a prescription-only medication. Effort should be taken to change these trading names and/or other materials to ensure that practitioners are not promoting the use or supply of prescription-only medications. |
| Booking consultations for procedures which include reference to prescription-only medication. | Unlawful | Advertising for a health service through the booking of a consultation for a procedure which identifies prescription-only medicines is unlawful. Instead, bookings for a health service of this nature should be rephrased as an 'initial' and 'review' cosmetic consultation with a practitioner. |
Although the Guidance will have a significant impact on how the industry advertises these procedures, no changes have been made to industry rules, regulations and legislation. We recommend that you get ahead of these changes, and role model compliance to not only avoid the attention of regulatory authorities, but to also maximise patient care and safety.
The above list is not exhaustive and may be subject to change at any time.
Please read the Guidance or seek further advice from our experts Scott Chapman and Angela Pale from the Sydney Health HWLE Team.
This article was written by Scott Chapman, Partner, Angela Pale, Senior Associate, and Sarah Morian, Solicitor.
