Advertising of Therapeutic Goods
Advertising of therapeutic goods is regulated quite strictly to promote socially responsible marketing and promotion, and quality use of therapeutic goods. Advertisements must not mislead or deceive the consumer.
There is a co-regulatory system and there are several governing laws and a Code:
- Therapeutic Goods Act 1989;
- Competition and Consumer Act 2010; and
- Therapeutic Goods Advertising Code (regarding advertising direct to consumers).
Advertisements can only refer to the indications included in the register for that good (this includes any statements, pictorial representations, and designs intended to directly or indirectly promote the use or supply of the goods). General rules about advertisements for therapeutic goods include:
- You must obtain an approval number prior to advertising;
- The publication must have the approval number in the bottom right hand corner of advertisement, and must be clearly legible;
- Advertisements must contain correct and balanced statements that can be substantiated; and
- Advertisements must be honest and clear and not misleading or likely to mislead in any way.
Depending on what category your therapeutic good falls under determines how you are allowed to advertise it, to whom, and whether you need special approval or not.
Prescription only medicines:
- You cannot advertise direct to consumers – you can only advertise to health professionals;
- Advertising is regulated by Medicines Australia and your advertisement must comply with their code of conduct;
- There may be other conditions assigned to the marketing approval of that particular product; and
- You do not require clearance unless you are making claims about the benefits of the product.
Remember that as of 1 February 2018 medicines containing codeine are prescription-only and therefore cannot be advertised to the public.
Non-prescription medicines:
Non-prescription medicines include: over the counter pharmacy medicines and non-prescription complementary medicines such as vitamins, homeopathic remedies, supplements, Chinese medicine, Australian Indigenous medicine, aromatherapy, Ayurveda medicine:
- Products should only be advertised as possible solutions for minor symptoms and conditions, and for maintaining health and wellbeing;
- For pharmacist-only medicines you can only advertise to health professionals;
- For the rest, you are able to advertise to both consumers and health professionals; however
- Advertisements direct to consumers will require prior approval by a delegate of the Secretary of the Department of Health and Ageing;
- Except – Complementary Medicines Australia is responsible for the regulation of complementary medicine outdoor advertisements and print media advertisements.
When advertising the use of vitamins, you must not imply that taking the vitamin is a substitute for good nutrition or a balanced diet, or that the vitamin is superior to dietary nutrients, or that a persons’ health may be adversely affected if they don’t take the vitamin.
Advertising over the counter analgesics:
- You must not imply consumption is safe;
- You must not imply that the analgesic will relax, relieve tension, sedate, or stimulate;
- Your advertisement must contain the statement “use only as directed. Incorrect use could be harmful. Consult your healthcare professional if symptoms persist.”
Medical Devices:
Medical devices can be advertised under similar rules to non-prescription medicines, however you can advertise directly to consumers without prior approval.
Journalism and advertorials:
Advertorials will of course be assessed as being an advertisement for the therapeutic good. For an article to qualify as real journalism and not fall under advertising regulations, it must:
- Not refer to the advertiser;
- Be independently researched and critically assessed by the journalist or an independent body;
- Present balanced information; and
- Pass the test of “Would a reasonable person believe the material is designed to promote the use or sale of a therapeutic product?”
Advertising techniques – what is allowed?
Sampling:
- Is forbidden except in the case of sun cream and therapeutic devices.
Scientific information:
- Must be clear and readily understood by intended audience;
- Must identify the researcher and financial sponsor in the advertisement; and
- Clinical observations and scientific trial outcomes must be presented in an accurate and balanced way so as not to be misleading.
Testimonials:
- Must be documented;
- Must be genuine; and
- Must illustrate typical cases only.
Comparative advertising:
- Must be balanced and not misleading.
Price-point advertisements (for supermarkets, pharmacies and health-food stores):
These advertisements are only allowed to state the brand name, price, style of goods, a photo or representation (containing no health claims) and the location and times the goods are for sale. Vouchers or articles by product ambassadors require further approval.
Advertising products intended for weight management:
Must have appropriate balance between claims made regarding the use of the product; and reference the importance healthy energy-controlled diet and physical activity for weight loss.
Prohibited representations in relation to therapeutic goods:
You must not advertise that products:
- Can cure, prevent or treat neoplastic STD’s, HIV, HCV, or mental illness.
Restricted representations allowed in some cases…
- Sun-creams may state that proper use of sun cream helps in the prevention of skin cancer; and
- Contraceptive products may represent prevention of pregnancy and/or prevention of transmission of disease between sexual partners.
However – any advertiser wishing to make restricted or prohibited claims must seek prior approval.
If you would like clarification about the rules and regulations relevant to your therapeutic good before advertising, speak to us. We can correctly apply for any required approval from the appropriate body, and ensure your product is marketed in a socially responsible way that does not attract (possibly damaging) complaints, or expensive legal problems.
This is general advice only. Liability limited by a scheme approved under Professional Standards Legislation.
Published Sep 25, 2018
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