The TGA (Therapeutic Goods Administration) has oversight of the advertising of therapeutic goods in Australia, in accordance with the Therapeutic Goods Act 1989. As a health professional, non-health professional, or corporate body advertising health services that involve therapeutic goods, you must comply with the requirements governing the advertisement of therapeutic goods. 

The simplest way to comply with the legislation is to avoid referring to therapeutic goods, such as prescription medicines and virtually all injectable treatments, when advertising your health service. However, there are potential pitfalls you must know about, and that’s why this guide will aid you greatly in navigating these rules.

Why the TGA Updated Its 2024 Advertising Guidance

Before 2024, the TGA permitted advertisers to indirectly refer to prescription medicines in advertisements for cosmetic health services. Hence, one could advertise using a generic, non-product-specific phrase, ‘wrinkle reducing injections’ instead of using the active ingredients themselves (Botox or Botulinum toxin) to ensure compliance. At that time, the TGA felt this would allow cosmetic clinics that offered these services to differentiate themselves from those that didn’t.

However, they reversed this stance when they started to notice other health service providers like weight loss clinics, medicinal cannabis clinics, and nicotine vaping services advertise prescription medicines using indirect references. Following this development, the TGA updated its guidelines to close the loophole that allowed advertisers to use generic references, such as “wrinkle-reducing injections” or “weight loss injections,” to advertise prescription goods. 

This change came on the heels of the resolution that a reasonable consumer would be able to interpret the advertisement as promoting the use or supply of prescription medicine despite the use of generic references. Moreover, prescription-only medication carries higher risks than over-the-counter medication, and decisions about their use should only be made in individual consultations with a health practitioner.

Prescription-Only Medicines: A TGA Advertising Red Line

Advertising therapeutic goods, such as prescription medicine, injectable treatments, and controlled drugs, to the public is prohibited under the law. The TGA defines advertising in relation to therapeutic goods as “any statement, pictorial representation, or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation, or design: 

1. is on the label of the goods; or 
2. is on the package in which the goods are contained; or
3. is on any material included with the package in which the goods are contained.”

The advertisement must be directed to the general public, and as little as a reference to a therapeutic good or an ingredient used in the manufacture makes it an advertisement of a therapeutic good. Furthermore, what determines whether the advertisement content is intended to promote the supply or use of therapeutic goods is what a reasonable consumer would understand the intent to be, not what the person responsible for the content intends.

Finally, any advertisement of therapeutic goods that is exclusively directed to health professionals does not constitute a breach of the guidelines. (Note that not all health professionals are included in this exemption.) However, it’s crucial that people who are not health professionals cannot access this advertisement. 

Ban on Indirect or Generic References

As previously discussed, the TGA permitted the use of indirect or generic references to prescription medicines in advertisements for cosmetic health services, allowing them to differentiate themselves from others who didn’t offer the same services. However, they sealed this loophole following the realisation that other health service providers, other than cosmetic health services, had exploited the opportunity.

What Advertisers Can and Cannot Do

If you’re advertising a regulated health service, let’s see what’s allowed under the TGA’s guidelines. You can:

• Advertise the service itself, e.g, ‘cosmetic consultations available’, ‘our clinic can provide consultations about reducing wrinkles’
• Describe what your clinic does in plain terms, but do not mention any prescription medicine
• Share general, evidence-based health content 
• Discuss the injectable treatment with a patient during a one-on-one consultation with a qualified healthcare professional in the clinic, where you can discuss the risks, benefits, and suitability of the treatment.
• Advertise injectable treatments directly to eligible healthcare professionals, provided the advert isn’t accessible to the general public.

 

How about what you can’t do? You cannot:

• Refer to prescription-only medicines, such as injectable treatments, in your advertisements.
• Use generic terms like wrinkle-reducing injections in your advertisements.
• Include references made directly or indirectly to prescription-only medicines through references such as a trade name, an abbreviation or acronym, and a colloquial name.
• Publish before-and-after images, testimonials or patient stories that suggest outcomes from injectable treatments.
• Offer gifts and inducements tied to injectable treatments.
• Include the price information of an injectable treatment in your advertisement.

Broader Code Requirements for All Therapeutic Goods Advertising

TGA’s code (The code) addresses all other therapeutic goods apart from injectables. The code exists to protect the public through appropriate advertising that is not misleading. Hence, it prohibits exaggeration of benefits or minimisation of adverse effects when advertising. Rather, adverse effects should be stated as clearly as the benefits. Any scientific claim must have substantial and explicit evidence to back it up. Finally, advertisements should not create an unreasonable expectation of benefit. Therefore, whether one is discussing a medication, weight loss injection, supplement, or a skin-injectable for cosmetic purposes, the same requirements exist to protect the public interest and ensure that advertising facilitates informed choice.

Enforcement, Compliance, and Industry Response

The TGA ensures compliance via:

1. Creating awareness and engagement, which involves assessing and letting advertisers remediate voluntarily
2. Enforcing rules with awareness and caution letters, letters of public awareness, letters of removal/suspension, monetary penalties, and even court action for certain or repeated violations. 

The TGA is most active where the most at-risk populations are, including cosmetic injections, medical cannabis, vapes and vaping, and weight-loss drugs. The new injectable requirements fall within a more extensive and planned crackdown. Some sub-industries respond better than others, from the TGA’s perspective and the industry’s ability to comply. Some clinics have already removed all references to injectables from digital marketing, while others need time. 

Practical Steps for Clinics and Advertisers

If you’re running a clinic or promoting available treatment, here’s how to keep compliant with your advertising and legal requirements:

1. First, acquaint yourself with the latest guidelines.
2. Review your advertising materials, including your website, social media, flyers, and any canvassing signage, for information about prescription drugs or injectables. Remove or amend items that are out of compliance.
3. Provide a service, not a product: talk about assessment procedure, practitioner credentials, patient care, but don’t talk about the products that are prescribed to them.
4. No testimonials and no freebies: turn off review capabilities on your website and do NOT provide discounts or free services for any clinically related treatment.
5. Educate your staff on the TGA’s advertising requirements.
6. If you have more extensive information for health professionals, ensure it is not available to the public.
7. Get it approved before it goes live: make it part of the process that any content undergoes the Code to ensure compliance before it goes live.

In conclusion, navigating TGA’s guidelines is not only about ensuring compliance. Your primary focus should be on ensuring the safety of the general public, particularly vulnerable populations. Always consider patient-centred care, safety precautions, and informed consent when advertising, and you’ll most likely stay compliant.