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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
The advertising regulatory framework
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.
Advertisements for therapeutic goods are subject to the requirements of the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990, the Competition and Consumer Act 2010, and other relevant laws. Advertisements for therapeutic goods directed to the public must also comply with the Therapeutic Goods Advertising Code (the Code).
Advertising and the Act
Section 3 of the Act defines advertise in relation to therapeutic goods to include:
- 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:
- is on the label of the goods; or
- is on the package in which the goods are contained; or
- is on any material included with the package in which the goods are contained
The 'intention' referred to in the definition above is not what you, as the advertiser, intend by releasing the information but rather what the end viewer thinks you intended. If the public or health professional considers that the information promotes the use or supply of the identified goods, then we would consider it an advertisement (see Activities that represent advertising).
- prohibits certain types of therapeutic goods from being advertised to the public
- contains a range of requirements that you must meet when advertising therapeutic goods. This includes the requirement for all therapeutic goods advertising to the public to comply with the Code.
- provides for a range of compliance and enforcement tools that the TGA may employ to address non-compliant advertising.
Advertising and the Code
The purpose of the Code is to ensure that the marketing and advertising of therapeutic goods to the public is conducted in a socially responsible manner that promotes the quality use of therapeutic goods and does not mislead or deceive the public.
On 1 January 2019, the current version of the Code (2015) will be replaced by the 2018 Code.
Replacing the 2015 Code with the 2018 Code
The 2018 Code contains a number of changes and improvements from the 2015 Code. The 2018 Code aims to:
- assist all advertisers in understanding the advertising requirements
- provide objective tests to determine breaches of the Code, which is needed to support the broadened sanctions and penalties (including infringement notices)
- address the inconsistencies between medicines and medical devices (where appropriate)
- incorporate changes to the Code that have been discussed with stakeholders in recent years but have been on hold while the advertising framework was under review.
A consultation on proposed improvements to the Code was held in August 2017.
The Therapeutic Goods Advertising Code 2018 is available on the TGA website, following public consultation on a draft of the 2018 Code.
There is more information on the transition arrangements for the 2018 Code on the TGA website.
Legal basis for the Code
Section 42BAA of the Therapeutic Goods Act 1989 (the Act) allows the Minister, or their delegate, to make a code relating to advertisements about therapeutic goods in the form of a legislative instrument.
It is a criminal offence under section 42DM of the Act to advertise a therapeutic good to consumers in a way that does not comply with the Code. Section 42DMA provides for corresponding civil penalties.
Limitations on advertising to the public
When advertising therapeutic goods to the public, you cannot advertise:
- indications for products that are not consistent with those indications that have been accepted in relation to the product's inclusion in the Australian Register of Therapeutic Goods (ARTG) (section 22, 32BJ and 41ML of the Act). Note that this requirement also applies to advertising to health professionals
- products containing ingredients specified in Schedules 3, 4 or 8 of the current Poisons Standard unless, in the case of Schedule 3 medicines, the ingredients appear in Appendix H of the current Poisons Standard (section 42DL(10) of the Act)
- biologicals (section 42DL(11) of the Act)
- autologous human cell and tissue (HCT) products excluded from being subject to therapeutic goods legislation, because one of the criteria for exclusion is not being advertised directly to consumers
- therapeutic goods that are required to be entered but are not in the ARTG (illegal therapeutic goods) (section 42DL(12) of the Act).
You are required to seek:
- a permission or approval from TGA before using Restricted representations (representations which refer to serious diseases or conditions) in advertising therapeutic goods to the public
- pre-approval before publishing advertisements for medicines appearing on television or radio, newspapers, consumer magazines, billboards and cinema films (section 42C of the Act and Part 2 Division 2 of the Regulations).
Section 6 of the Act limits the operation of the Act, and therefore the Code, to
- activities by corporations; and
- activities by natural persons:
- in the course of, or in preparation for, trade or commerce between Australia and a place outside Australia, among the States, between a State and a Territory or between 2 Territories; or
- under a law of the Commonwealth relating to the provision of pharmaceutical or repatriation benefits; or
- in relation to the Commonwealth
As such, neither the Act, nor the Code, apply to sole traders that operate solely within the state or territory in which they are based. However, advertisers should be aware that the promotion of therapeutic goods online may be considered trade or commerce across state/territory borders and therefore the Act and Code may apply. Sole traders operating solely intrastate should also be aware that some states and territories have adopted the advertising requirements in the Act and the Code.
The advertising requirements in the Act and the Code only apply to the advertising of therapeutic goods, as defined in section 3 of the Act. The advertising of goods that are not therapeutic goods, including foods and goods excluded from the operation of the Act under sections 7 or 7AA, is not subject to the requirements of the Act and the Code. However, some goods, when advertised with therapeutic claims, may be considered therapeutic goods. See advertising interface products and Complementary medicines interface issues for more information.
When preparing to advertise therapeutic goods to the public, you will need to consider other legal requirements as well as those set out in the Act and the Code.
Other relevant laws include:
- Australian Consumer Law
- National Health Practitioner Law (where the advertiser is a regulated health practitioner)
- State and territory poisons and other legislation.
Depending on a range of factors, including the advertising medium used, there may also be self-regulatory requirements that apply. For example:
- Advertisements to appear on free-to-air television require clearance by FreeTV Australia's Commercial Advice
- Advertisements to the public from sponsors of therapeutic goods may be captured by their industry organisations' respective self-regulatory codes. For example:
- Australian Self Medication Industry Code of Practice;
- Complementary Medicines Australia Marketing & Supply Code of Practice: Complementary Medicines;
- Medical Technology Association of Australia Code of Practice; and
- IVD Australia Code of Conduct.
The Communications Council has a useful list of advertising codes and regulations that apply in Australia.
Quality use of medicines
The therapeutic goods advertising legislation is 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 use in the care of themselves or their family.
To support the principles of the QUM framework, industry should be able to provide truthful information to potential consumers about the nature and benefits of therapeutic goods. They should be able to do so through responsible advertising, where this will enhance the health outcomes of the Australian people.
In this context, the Code is pivotal to establishing a robust and effective system for regulating advertising of all therapeutic goods to the public. It aids in giving consumers confidence that the claims they read and hear are well-founded, and it should provide a level playing field for industry.
In the event of any inconsistency between the Act or the Code and other policies, the Act and the Code prevail.
World Health Organization criteria
The advertising legislation, especially the Code, also draws on concepts used in the World Health Organisation: 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, 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.