The following guidance supports pharmacists to produce compliant advertising of therapeutic goods (devices and medicines) and professional health services.
Pharmacists should be aware that there are many laws that relate to advertising and pharmacy.
|Advertising therapeutic goods||Therapeutic Goods Act 1989|
Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021
|Advertising regulated health services||Health Practitioner Regulation National Law|
|Advertising related to the Pharmaceutical Benefits Scheme (PBS)||National Health Act 1953|
|Pharmacy ethics and standards||PSA Code of Ethics|
PSA Professional Practice Standards
|Australian advertising laws||Australian Consumer Law|
Competition and Consumer Act 2010
Local government (council) regulations related to signage.
Do not mislead through omission or unfair contrast.
Ensure claims are consistent with the therapeutic good’s ARTG listing and in accordance with directions for use. Do not advertise indications not on the ARTG.
Support claims with references that accurately represent them, and use plain language when explaining evidence.
Advertise, in relation to therapeutic goods, includes making 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:
'Short form' advertisements include:
Advertisements in social media are not considered 'short form advertisements' because they either have capacity to include all the applicable mandatory statements in the advertisement itself or they can include links to all the applicable mandatory statements.
Short form advertisements must contain the following statement, prominently displayed or communicated:
‘ALWAYS FOLLOW THE DIRECTIONS FOR USE’
For more details refer to ‘Mandatory statements and other required information’ in the Therapeutic Goods Advertising Code.
The term “therapeutic good” is defined in section 3 of the Therapeutic Goods Act 1989. It includes medicines, biologicals, medical devices and other therapeutic goods such as disinfectants and tampons. “Medicines” includes prescription, over-the-counter and complementary medicines. Most sunscreens are also considered to be therapeutic goods.
Some products advertised by pharmacies are not therapeutic goods. Examples include cosmetics, foods, and consumer goods. These products are regulated by state/territory food regulation legislation and/or other legislation. See the “advertising ordinary consumer goods FAQ” below.
If an advertisement for a cosmetic, food or consumer good makes a therapeutic claim, then the requirements of the Therapeutic Goods Advertising Code will apply.
Some therapeutic goods cannot be advertised. Do not advertise prescription medicines (S4, S8). Only advertise pharmacist only (S3) medicines that are listed in Appendix H of the Poisons Standard.
Price lists for S3, S4 and S8 medicines (not in Appendix H of the Poisons Standard) can be published under certain conditions, but the presentation of these lists is heavily regulated.
Do not make any claims that are contrary to the information on the label, or otherwise supplied with the good.
Do not make claims about efficacy that are unrealistic for an average consumer, encourage inappropriate use, or discourage prescribed treatment.
Do not claim that consumption of a particular analgesic is safe, will relax, relieve tension, sedate or stimulate.
Avoid any implication that vitamins and minerals are a substitute for good nutrition or express the quantity of a vitamin or mineral contained in a preparation as a percentage or a proportion of the recommended daily intake.
Sunscreen advertisements must not present sunscreen as the only necessary protection against the sun.
Claims about weight loss products must not imply that they are substitutes for a controlled diet and physical activity.
Advertisements must not contradict a current public health campaign.
Warning statements are mandatory and specified under Part 4 of the Therapeutic Goods Advertising Code (TGAC).
Some particular therapeutic goods require additional warning statements:
Refer to Part 4 of the Therapeutic Goods Advertising Code (TGAC) for other required information.
A testimonial is an instance of someone speaking or writing about their experience using a therapeutic good, such as a medicine or device.
Therapeutic goods must not be recommended by a healthcare professional (this might be implied by an image, or words used in the text), a government authority (unless otherwise permitted by the Act), or an individual involved in or in any way connected to the production or sale of the good.
You must verify the identity of the person making a testimonial and their claims about the good before using their words as content.
Testimonials must be consistent with the good’s label, instructions for use and intended purpose (as listed on the ARTG), and must describe benefits that are typical for an average consumer.
If a non-compliant testimonial appears on a website or social media channel that you control, the expectation is that you will remove it (or remove non-compliant elements) within a reasonable period.
An endorsement of a therapeutic good is a recommendation and might take the form of the recommending organisation’s brand appearing in the advertising. If this does occur, it must be accompanied by clear statements about any valuable consideration the organisation has received or will receive for the endorsement.
An endorsement about therapeutic goods must not be given by a government authority unless permitted by the Act or Regulations.
Therapeutic good endorsement by a health organisation can only be used if the name of the organisation is disclosed along with any valuable consideration the organisation has received in return for the endorsement.
The only healthcare facilities permitted to endorse therapeutic goods are community pharmacies, but endorsements must not be given by pharmacy employees or contractors.
Endorsements by individuals such as healthcare practitioners, or persons who represent themselves as being trained to diagnose or prevent disease, ailment or injury, are not permitted.
Any social media post promoting a therapeutic good is an advertisement. As with other forms of advertising, pharmacists must carefully consider the relevant legislation when making posts to avoid serious risks.
Social media posts are not considered ‘short form advertisements’ under the TGAC and therefore must include full health warnings.
The TGA recommends that mandatory statements appear at the top of any social media post promoting a therapeutic good. If mandatory statements do not appear in full on the first visible screen displaying the promotion, the advertisement is not compliant. Ensure that no part of a mandatory statement requires user interaction e.g. ‘click to expand’, to be fully displayed.
The act of reposting a third-party post carries with it the responsibility of ensuring compliance of the post as it appears to consumers of your social media feed.
A reshare/tweet has a slightly different appearance to the original post, therefore if an original post is compliant, it does not follow that your reshare will be compliant. Differences will also arise when sharing to another platform, such as sharing a Tweet to your Facebook channel. Double check the appearance of the post is compliant before posting.
Posting from your own professional social media account (for example on LinkedIn) will have a different meaning to a business social media account (for example on Twitter) under the name of your pharmacy.
Take care of text you add when resharing and how that text may change the meaning or intention of the original post.
You can offer samples of condoms and personal lubricants, COVID-19 rapid antigen tests for self-testing, sunscreens, hand sanitisers, tampons and menstrual cups, continence catheter devices for self-management etc. A full list can be found in Annexure 2 – Samples of the TGAC.
The TGA restricts or prohibits the representation of serious health conditions in advertising materials. Avoid:
Refer to the TGA advice on restricted and prohibited representations.
Research must be identified, including financial sponsor, and communicated in a readily understood manner.
Avoid representing complex statistical data including graphs and scientific jargon that would not be readily understood by the average consumer.
Only use supporting studies from verifiable sources and studies that are consistent with the body of evidence applicable to the goods and that consumers can easily access.
Do not exaggerate or misrepresent the conclusions of a study.
Therapeutic goods cannot be advertised to children under 12 years.
Some therapeutic goods (those listed in Annexure 1 of the Therapeutic Goods Advertising Code) can be advertised to children over 12 years, provided those goods do not contain Schedule 2, 3, 4 or 8 substances. Allowable goods include tampons, acne preparations, sunscreens with SPF 15+, condoms and personal lubricants, bandages and wound dressings, cold sore preparations, lip balm and anti-dandruff preparations.
Be factual and promote your health service on its merits.
Do not create any unreasonable expectation or attempt to induce consumers to use the service unnecessarily, including by way of gifts or discounts.
Be honest in relation to your business practices.
Ensure that any person promoting a health service as a health professional – including in a representation of that person – is registered to practise as the health professional they claim to be or are purported to be.
Consider your audience and ensure that your advertising will be easy for them to navigate and understand.
Advertisements of health services must not mislead or deceive consumers. Avoid:
No. Testimonials and purported testimonials of regulated health services can create unreasonable expectations and encourage unnecessary use of a service. As such they are prohibited.
Do not use consumer stories or success stories regardless of whether they are real or constructed for the purpose of the advertisement.
If a consumer does appear in your advertisement, ensure they do not make comments of a clinical nature. They must not mention symptoms, diagnosis, treatment or outcome of the service.
If a review of a service appears in a forum you have control over (e.g a pharmacy business social media channel), then you are responsible for compliance.
The Health Practitioner Regulation National Law only uses the term ‘endorsement’ in the sense of a training body endorsing a health care practitioner as capable of providing a particular kind of health service. Under the National Law a Chiropractor, for example, may claim to have obtained an acupuncture endorsement from a relevant accrediting body.
The National Law protects specialist titles and prohibits claims that a health practitioner holds specialist registration, qualifications or endorsements when they do not.
The National Law is silent on endorsements in the sense used in the TGAC, where an organisation endorses a product or service (as something that satisfies the standard set by the organisation).
If depicting a health benefit, ensure it is clear how that health benefit arises from the service, and take care the benefit is not exaggerated.
Avoid altering or enhancing images.
If using before and after images, be consistent in elements that are unrelated to the health service such as make up, posture clothing, lighting etc.
Be careful of making any such representations as these will need to be compliant with the Therapeutic Goods Advertising Code. A representation of a vaccine package, for example, is likely to be a prescription medicine and therefore prohibited.
Refer to ‘Advertising therapeutic goods FAQ’ above for more detail.
Any social media post promoting a health service is an advertisement and all requirements under the Health Practitioner Regulation National Law apply.
Before posting about a health service on social media, pharmacists must carefully consider the above information in this FAQ, especially the questions relating to testimonials, images and representations of medicines or medical devices.
Posting from your own professional social media account (for example on LinkedIn) will have a different meaning to a pharmacy business social media account (for example on Twitter).
The act of resharing a third-party post brings with it the burden of ensuring that post is compliant.
The Health Practitioner Regulation National Lawis clear that testimonials about health services are prohibited. If you find a testimonial about a health service on social media, do not reshare it.
A reshare/tweet has a slightly different appearance to the original post, therefore if an original post is compliant, it does not follow that your reshare will be compliant. Differences will also arise when sharing to another platform, such as sharing a Tweet to the pharmacy Facebook channel. Double check the appearance of the post is compliant before posting.
Take care of text you add when resharing and how that text may change the meaning or intention of the original post.
The principles of Australian Consumer Law apply to all advertising and sales techniques for any kind of product regardless of whether they are therapeutic goods and regulated health services or ordinary consumer goods. The most basic principles are:
The Therapeutic Goods Advertising Code applies to therapeutic goods such as medicines, medical devices and sunscreens.
The Code also applies to cosmetics, foods and other consumer goods if a therapeutic claim is made when that product is advertised.
To assist in determining whether a product would be considered a therapeutic good refer to:
Some hand sanitiser products are therapeutic goods, in particular if they make claims about killing viruses or specific pathogens. However, other hand sanitisers are consumer goods which are not subject to TGA regulation.
The Australian Competition and Consumer Commission (ACCC) is the primary regulator for cosmetics and is responsible for consumer safety, ingredient labelling and claims of cosmetic products. The TGA has published a guide to the regulation of cosmetics as therapeutic goods.
Ther are two guiding documents for the promotion of infant formula in Australia, the MAIF Agreement and the International Code of Marketing Breastmilk Substitutes.
The MAIF agreement is a voluntary, self-regulatory, code of conduct between the manufacturers and importers of infant formula. Compliance is monitored by the Department of Health.
Pharmacies are not bound by these codes, however marketing of infant formula and associated products is a sensitive area for which special consideration may be given to mitigate reputational risks.
The Infant Nutrition Council provides an information brochure for retailers with more information about the MAIF.
Unicef provides a guide for health practitioners for working within the International Code of Marketing Breastmilk Substitutes.