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Advertising to the public
Complying with the Therapeutic Goods Advertising Code (No. 2) 2018
About the Code and this guidance
The Code sets out minimum requirements for advertisements about therapeutic goods directed to the public. It is a legislative instrument made by the Minister or their delegate under section 42BAA of the Therapeutic Goods Act 1989 (the Act). There are criminal offences and civil penalties for advertising to the public that does not comply with the Code.
Object of the Code
The Code exists to ensure that the advertising of therapeutic goods to the public is conducted in a manner that:
- promotes the safe and effective use of therapeutic goods by minimising misuse, overuse or underuse
- is ethical and does not mislead or deceive the consumer or create unrealistic expectations about product performance
- supports informed health care choices
- is not inconsistent with relevant current public health campaigns
Reading the Code
In the event of any inconsistency between the Act, the Regulations or the Code and this guidance or other published policies, the Act, the Regulations and the Code prevail.
This guidance is designed to be read in conjunction with the Code and its Explanatory Statement to provide further information about the understanding, interpretation and application of the Code provisions. Unless otherwise stated, the Code requirements apply to all elements of advertising (including both therapeutic claims and non-therapeutic claims) and all types of advertising to the public.
The Act, the Therapeutic Goods Regulations 1990 (the Regulations) and the Code contain explicit definitions for certain terms. Where a term is not defined the normal meaning, derived from the current edition of the Macquarie Dictionary, applies.
In reading the Code provisions, note that the conjunctions 'and', 'or' have different meanings:
- the conjunction 'and' signifies that each paragraph set out in the provision applies
- the conjunction 'or' puts each paragraph as an alternative such that only one of the paragraphs needs to be satisfied in order for the provision to apply
- where no conjunction is used, 'and' is implied unless the wording is clear that each itemised paragraph is an alternative
A reference to a noun that is singular is taken to include plural forms, for example 'medicine' also includes 'medicines'.
A reference to 'person' in the Act, the Regulations or the Code includes individuals, organisations and corporate entities.
Certain sections of the Code also apply to generic information. See Generic information below.
This guidance provides examples of the application of the Code and, where relevant, includes 'decision highlights' from the Complaints Resolution Panel (CRP). The CRP was responsible for the handling of many complaints about advertisements for therapeutic goods from 1999 to June 2018. This guidance is supplemented by fact sheets on major topics.
Examples provided in this guidance are provided to illustrate the information provided and are not intended to be either comprehensive or exhaustive in relation to the application of the Code.
With the exception of CRP matters, all examples used in this guidance have been compiled to demonstrate the application of the legislation. They should not be taken to be a reference to any particular advertisement.
Other relevant policies and principles
The Code draws on concepts used in the World Health Organization: Ethical Criteria for Medicinal Drug Promotion 1988, namely:
- promotion refers to all informational activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal products
- all promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, and capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or give rise to undue risks
- comparison of products should be factual, fair and capable of substantiation
- advertisements to the general public should help people to make rational decisions on the use of drugs determined to be legally available without prescription. While they should take into account people's legitimate desire for information regarding their health, they should not take undue advantage of people's concern for their health, nor mislead the consumer into unwisely relying on medicines to solve physical, emotional or mood problems
- the provision of free samples to the general public for promotional purposes is difficult to justify from a health perspective
- advertisements may claim that a drug can cure, prevent or relieve an ailment only if this can be substantiated
- language which brings fear or distress should not be used
- advertisements should not be allowed for certain serious conditions that can be treated only by qualified health practitioners
The Code is also grounded in the Quality Use of Medicines (QUM) framework. Quality Use of Medicines means:
- selecting management options wisely by:
- considering the place of medicines in treating illness and maintaining health, and
- recognising that there may be better ways than medicine to manage many disorders
- choosing suitable medicines if a medicine is considered necessary so that the best available option is selected by taking into account:
- the individual
- the clinical condition
- risks and benefits
- dosage and length of treatment
- any co-existing conditions
- other therapies
- monitoring considerations
- costs for the individual, the community and the health system as a whole
- using medicines safely and effectively to get the best possible results by:
- monitoring outcomes
- minimising misuse, over-use and under-use, and
- improving people's ability to solve problems related to medication, such as negative effects or managing multiple medications
Under the QUM framework, consumers should be able to select management options wisely; choose suitable medicines (if a medicine is considered necessary); and use medicines safely and effectively. Similar considerations apply to medical devices and other therapeutic goods that may be appropriate for self-selection by consumers for their care or their family's care.
To support the principles of QUM, advertisers should provide truthful information to potential consumers about the nature and benefits of therapeutic goods. They should be able to do so through responsible advertising.