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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
Advertising therapeutic goods with related services
We are aware that a member of the public has asked a medical clinic to remove vaccination posters, implying that he is an officer of the TGA. Posters relating to vaccines sanctioned by the Australian Government Department of Health under the National Immunisation Program are permitted by the therapeutic goods advertising requirements.
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:
- Medical Board of Australia
- Pharmacy Board of Australia
- Australian Consumer Law
- Australian Health Practitioner Regulation Law (and applicable advertising guidelines)
- state and territory laws
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 and vaccines
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. The only exception to this prohibition is advertising that has been authorised or required by a government or government authority within Australia (subsection 42DL(10) of the Act).
This means that a clinic displaying an advertisement in the form of a National Immunisation Program poster produced by the Australian Government (the Advertisement) that promotes particular vaccines and vaccination would not breach the prohibition.
Advertisers who display such an advertisement must ensure that:
- the Advertisement has been genuinely issued by either the Australian Government or a government of an Australian state or territory
- the Advertisement itself has not been altered in any way, unless expressly provided for in the Advertisement (e.g. where a space has been included for the express purpose of allowing clinics to add dates and times for vaccine availability)
- the take-out message of the Advertisement is not altered in any way, including through the use of additional promotional messages proximate to the Advertisement
- A health provider displays in their clinic an Australian Government health campaign poster about the influenza vaccine. No additional promotional messages or information was included near the poster and the poster itself is unaltered. While the poster is advertising prescription-only medicines, the advertisement itself is not in contravention of the Act.
- A health provider displays in their clinic an Australian Government health campaign poster about the influenza vaccine but added a note below the poster stating 'we only use [brand x] vaccines'. This additional information is promotional and would be interpreted in the context of the poster above it. As a whole, the poster and additional information would be in contravention of the Act.
Public health campaigns relating to vaccination, in addition to referring to prescription-only vaccines, invariably use representations which refer to serious forms of diseases (i.e. vaccine preventable diseases). Such representations are 'restricted representations' which must not be used in advertisements for therapeutic goods prior to approval or permission from the TGA. The TGA has given permission for advertisements that are government public health campaigns, to contain 'restricted representations'.
Advertising vaccination services
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 is considered an advertisement for a therapeutic good which, outside of the context described above, would be likely to contravene the Act.
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:
- of the vaccine type, for example, trivalent or quadrivalent
- that influenza vaccines are free to people from high risk groups identified in the National Immunisation Program Schedule
- that people from high risk groups should seek advice from their medical practitioner.
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.