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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)

Guidance for advertisers

8 November 2018

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Advertising therapeutic goods with related services

This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015 but incorporates amendments to the Therapeutic Goods Act 1989 (the Act) that came into effect on 6 March 2018, and has been further updated to provide specific information on advertising biologicals and to also include more background information on advertising requirements.

The Therapeutic Goods Advertising Code (No.2) 2018 was made on 31 October 2018 to replace the 2018 Code which will come into effect on 1 January 2019. A summary of the changes is available. To assist advertisers with implementation, we have also published guidance material; Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.

Advertising health services

TGA does not regulate the advertising of health services. We do not consider advertisements solely for health services to be advertisements for therapeutic goods.

To ensure that your advertisement for a health service isn't also considered an advertisement for therapeutic goods, do not refer (either directly or indirectly) to any therapeutic goods used in the delivery of the service in the advertisement.

This may be difficult for services that inherently involve therapeutic goods, for example, imaging or vaccination services. Such advertisements will need to comply with the legislative requirements for advertising therapeutic goods as well as any requirements governing the advertising of services.

Requirements when advertising health services

You should be aware that there are requirements that apply when advertising health services, such as:

Advertising extemporaneously compounded medicines

Advertisements for extemporaneously compounded medicines must comply with the Act and other relevant laws, including the Health Practitioner Regulation National Law (and applicable advertising and dispensing guidelines), the Australian Consumer Law, and State and Territory Laws. Extemporaneously compounded medicines, although exempt from some parts of the Act, are not exempt from the advertising provisions of the Act.

Generally, it is unlawful to publish or broadcast an advertisement to consumers for an extemporaneously compounded medicine, that:

  • refers to a substance (any ingredient of a medicine) or a good containing a substance classified in the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) as a pharmacist only medicine (Schedule 3), prescription only medicine (Schedule 4) or controlled drug (Schedule 8) (some exceptions apply); or
  • has not been pre-approved by the Secretary of the Department of Health, if that advertisement is for a 'designated therapeutic good' published or broadcast in 'specified media'.

Applying advertising provisions to extemporaneously compounded medicines

Both a medicine and an ingredient used in the manufacture of a medicine is a therapeutic good.

The advertising requirements in Part 5-1 of the Act apply to advertisements that are:

  • directed to the general public; and
  • for therapeutic goods, even where an advertisement also promotes other goods or services that are not therapeutic goods.

The advertising provisions in Part 5-1 of the Act do not apply to advertisements:

  • for services, for example an advertisement that only promotes the service of extemporaneously compounding medicines, that do not promote or impliedly promote any therapeutic goods
  • that are directed exclusively to health professionals (however, not all health practitioners are included in this exemption).

Advertisements for extemporaneously compounded medicines must not refer to any medicine that contains a restricted scheduled substance, even where:

  • the restricted scheduled substance is one of several ingredients, including substances that are not restricted scheduled substances; or
  • the advertisement does not refer to the restricted scheduled substance by name.

There is an exception, to the offence of advertising a medicine that contains a restricted scheduled substance, for those Schedule 3 substances listed in Appendix H to the current Poisons Standard. Please note that there are certain exemptions from the scheduling requirements which may also apply.

Some advertisements for non-scheduled medicines require pre-approval

It is an offence to publish or broadcast in 'specified media' an advertisement about 'designated therapeutic goods' to the general public unless your advertisement has been pre-approved by the Secretary of the Department of Health (section 42C of the Act).

Generally, 'designated therapeutic goods' will include any extemporaneously compounded medicines that do not contain a restricted scheduled substance.

Advertising vaccination services

All vaccines for human use are classified as prescription-only medicines (Schedule 4) in the Poisons Standard. You cannot advertise prescription-only medicines to consumers (subsection 42DL(10) of the Act).

We do not regulate the advertising of health services but if your advertisement for a vaccination service also promotes the use of a therapeutic good it may then become an advertisement of a therapeutic good.

What to avoid when advertising vaccination services

When advertising vaccination services, avoid using:

  • information that might enable consumers to identify the particular vaccine or the manufacturer of the vaccine provided with the service
  • statements or representations that harmful effects will occur from not receiving the vaccine
  • references to any misleading therapeutic benefit of a vaccine (for example, a use that is not a TGA-approved indication for the vaccine)
  • an indication that the vaccine administered as part of the service is superior to other vaccines
  • portrayals of the vaccine or service in a way that trivialises or conflicts with public health policies, or misleads consumers in any other way
  • price comparisons
  • incentives to encourage the consumer to obtain the service or vaccine, or
  • any other claim that promotes the use or supply of the vaccine

Use of any of the above makes advertising of your service to be more likely considered advertising of the vaccine itself and subject to therapeutic goods legislation.

What to include when advertising vaccination services

We recommend that advertisements for seasonal influenza vaccination services should inform the public:

High risk groups eligible for free influenza vaccines

High risk groups that are eligible for free influenza vaccines include:

  • Aboriginal and Torres Strait Islander people aged 0 to 5 years
  • Aboriginal and Torres Strait Islander people who are aged 10 years and over
  • pregnant women
  • people aged six months and over with medical conditions such as severe asthma, lung or heart disease, low immunity or diabetes that can lead to complications from influenza
  • people aged 65 years and over.

Advertising cosmetic services and injections

Advertising cosmetic services containing Schedule 4 substances

You cannot publish an advertisement to the public about therapeutic goods that contains a statement referring to goods, or substances or preparations containing goods, included in Schedules 3, 4 or 8 of the Poisons Standard (section 42DL(1)(f) of the Act).

The products listed below (and most cosmetic injections) contain substances that are in Schedule 4 of the current Poisons Standard and are therefore regulated as Prescription Only Medicines:

  • Anti-wrinkle injections
  • Dermal Fillers
  • Improvement of the appearance of submental fat

Cosmetic injections are generally administered to temporarily remove/reduce wrinkles and lines on the face, around the eyes, forehead (anti-wrinkle injections and dermal fillers), lips and neck (dermal fillers only) or to improve the appearance of submental fat (deoxycholic acid).

We consider prescription medicines to be high risk products and the patient should be assessed by a medical professional before their use. Health professionals and cosmetic or beauty clinics are not permitted to advertise cosmetic injections (such as those above) to the public.

Some cosmetic injections may be compounded by a pharmacy for an individual patient rather than supplied by a manufacturer as a finished product. The advertising of compounded cosmetic injections that contain prescription-only substances to the public is also prohibited. For more information, see Advertising extemporaneously compounded medicines.

Advertising cosmetic injections compliantly

To continue legally promoting your cosmetic service to the public, there are some acceptable general terms that you can use to describe certain cosmetic injections in advertisements.

You cannot make any reference in your advertisement to:

  • individual Schedule 4 substances or ingredients
  • therapeutic goods containing Schedule 4 substances or ingredients (most injections for cosmetic use).

This includes abbreviations of either the ingredient or trade names.

Acceptable general terms

You may use the following acceptable general terms and phrases in your advertising (noting a therapeutic good must not be advertised for an indication or intended purpose that is not accepted in relation to the inclusion of the good on the ARTG):

  • cosmetic injections (anti-wrinkle injections, dermal fillers and submental fat)
  • anti-wrinkle injections/treatments (anti-wrinkle injections and dermal fillers)
  • wrinkle injections/treatments (anti-wrinkle injections and dermal fillers)
  • injections/treatments for lips (dermal fillers)
  • injections/treatments for fine lines/folds/age lines (anti-wrinkle injections and dermal fillers)
  • wrinkle and lip enhancement/fulfilment/augmentation (dermal fillers)
  • injections to enhance pouting of the lips (dermal fillers)
  • injections which reduce the depth of fine lines/wrinkles around the face/lips (dermal fillers)
  • injections to improve the appearance of chin/neck/jaw line (dermal fillers)
  • injections for improving the appearance of submental fat/fullness under the chin. (submental fat)

You may also use other words and phrases with similar meaning, provided that they do not refer to specific products or ingredient names. It is not acceptable to use acronyms, nicknames, abbreviations or hashtags of the medicine's name (or some part thereof), which may be taken by a consumer to be a 'reference' to a specific medicine or substance.

You may also have obligations under the Competition and Consumer Act 2010 and state and territory fair trading/consumer affairs legislation.

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