EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ADVERTISING CODE 2005
Subsection 3(1), Therapeutic Goods Act 1989
BACKGROUND
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
The Act includes provisions relating to advertisements for therapeutic goods, including a number of provisions that require advertisements for therapeutic goods to comply with the Therapeutic Goods Advertising Code.
Subsection 3(1) of the Act defines the Therapeutic Goods Advertising Code (the Code) as the Code known by that name and “notified in the Gazette with effect from the date of commencement of Schedule 1 to the Therapeutic Goods Amendment Act (No.1) 2003 together with any amendments of the Code published by the Minister in the Gazette from time to time”.
The Code is now subject to the Legislative Instruments Act 2003, requiring it and all subsequent amendments to be included in the Federal Register of Legislative Instruments (FRLI).
The Parliamentary Secretary has approved a number of amendments to the Code, which are incorporated into the Therapeutic Goods Advertising Code 2005. The opportunity was also taken to renumber the sections of the Code to align it more closely to the standards required for FRLI. The Therapeutic Goods Advertising Code 2005 replaces the previous Code which was made on 16 July 2003 (and subsequently amended by the Therapeutic Goods Advertising Code: Amendments (20/01/05)) (‘the previous Code’).
The Code commenced on the day after it was registered in FRLI.
DETAILS OF AMENDMENTS TO THE CODE
The Code includes the following amendments which have been approved by the Parliamentary Secretary to the Minister for Health and Ageing.
Subsection 4(6) (formerly Clause 4.4 in the previous Code) is amended to change the requirements surrounding government agency and health professional endorsements in advertisements for therapeutic goods. While the prohibition on government agency endorsement will remain, the amendment permits sponsors to include reference in advertisements to any sponsorship arrangements they may have with government agencies. The proposed amendment will, for the first time, also permit individual healthcare professionals to endorse therapeutic goods in advertisements, providing the nature and basis of the endorsements are clearly disclosed in advertisements.
Subsection 4(7) (formerly Clause 4.5 in the previous Code) is amended to change the requirements relating to the use of testimonials in advertisements. The amendment requires that testimonials may now only show ‘typical’, rather than ‘exceptional’ cases.
Section 6 (formerly Clause 6 in the previous Code) is amended to require that the (already) mandatory display of approval numbers in print media advertisements, is now carried out by advertisers following a uniform approach.
Paragraph 7(1)(c) (formerly Clause 7.1.2 in the previous Code) is amended to clarify that the mandatory warning statements specified in the TGAC for analgesic products do not need to also appear on the product labelling, since label warning statements are already prescribed by the “Standard for the Uniform Scheduling of Drugs and Poisons”.
Subsection 7(3) (formerly Clause 7.3 in the previous Code) is amended to complement the amendment to Subsection 4(7), and changes the requirements for the advertising of weight loss products. The amendment aims to ensure that advertisements, as well as promoting the advertised product, also include an appropriate balance between healthy eating and exercise in order to achieve safe and sustainable weight loss.
CONSULTATION
These amendments to the Code, based on a best-practice approach, have been considered and recommended to the Parliamentary Secretary by the Therapeutic Goods Advertising Code Council (TGACC). The TGACC is established in the Therapeutic Goods Regulations to consider the requirements for the advertising of therapeutic goods and changes to the Code, and to advise the Minister accordingly.
The TGACC is broadly representative of all major stakeholder groups, including the therapeutic goods and advertising industries, media, consumers, healthcare professionals and government. Via their membership of the TGACC, all these stakeholder organisations have been consulted and directly involved with the development of the above amendments to the Code.
Overview
The Therapeutic Goods Advertising Code 2005 was enacted to provide a regulatory framework for advertisements of therapeutic goods in Australia. This legislative instrument was introduced to address the need for a comprehensive set of guidelines and standards that govern the advertising of therapeutic goods, ensuring that such advertisements are truthful, balanced, and do not mislead consumers. This Code replaces the previous Therapeutic Goods Advertising Code which was made on 16 July 2003. The amendments to the Code approved by the Parliamentary Secretary aim to modernise the regulatory approach, including changes to the requirements for government agency and health professional endorsements, the use of testimonials, the display of approval numbers, and the advertising of weight loss products. These amendments were developed with input from the Therapeutic Goods Advertising Code Council, ensuring a broad representation of stakeholder interests. The policy objective is to maintain and enhance the quality, safety, and efficacy of therapeutic goods advertising, thereby protecting public health.
Scope and Application
The Therapeutic Goods Advertising Code 2005 applies to all persons and entities involved in the advertising of therapeutic goods in Australia, ensuring compliance with the requirements set out in the Therapeutic Goods Act 1989. This includes a wide range of industries such as pharmaceutical companies, medical device manufacturers, and health service providers, as well as individual healthcare professionals who may endorse therapeutic goods in advertisements. The Code establishes strict guidelines on how therapeutic goods can be advertised to ensure that the information provided is truthful, balanced, and does not mislead consumers. The jurisdictional reach of this Act is national, applying uniformly across all states and territories of Australia. Notably, the Act excludes certain categories of therapeutic goods from its scope, such as those regulated under the Standard for the Uniform Scheduling of Drugs and Poisons. The Act may also extend or restrict its application through subordinate instruments, allowing for more detailed regulations and guidelines to be issued under the authority of the Therapeutic Goods Administration. These amendments and the overall framework are designed to maintain the highest standards in the advertising of therapeutic goods, protecting public health and safety.
Key Provisions
The Therapeutic Goods Advertising Code 2005, under the Therapeutic Goods Act 1989, governs the advertising of therapeutic goods in Australia. The Code, referenced in subsection 3(1) of the Act, was updated and renumbered to better align with legislative standards. It includes several key sections that outline specific requirements and restrictions on advertising practices. For example, subsection 4(6) now allows references to sponsorships by government agencies in advertisements, while maintaining a prohibition on direct endorsements by these agencies. Additionally, individual healthcare professionals can now endorse therapeutic goods in advertisements, provided the nature and basis of the endorsements are clearly disclosed (subsection 4(7)). Section 6 mandates a uniform approach for displaying approval numbers in print media advertisements, ensuring consistency across all such ads.
The Code imposes several obligations on the parties it governs. Advertisers must adhere to the new requirements concerning testimonials, which now only allow the presentation of 'typical' cases, not 'exceptional' ones (subsection 4(7)). They must also clearly disclose any sponsorship arrangements with government agencies and the nature of any healthcare professional endorsements (subsection 4(6)). Furthermore, advertisers are required to follow a uniform method for displaying approval numbers in print media advertisements (Section 6). Paragraph 7(1)(c) clarifies that warning statements specified in the Code for analgesic products do not need to be duplicated on the product label, as label warnings are already prescribed by the "Standard for the Uniform Scheduling of Drugs and Poisons" (paragraph 7(1)(c)).
There are also civil and criminal consequences for non-compliance with the Therapeutic Goods Advertising Code 2005. Violations can result in significant penalties, including fines and imprisonment. For example, misleading or deceptive advertising practices can attract penalties under section 42 of the Therapeutic Goods Act 1989, which provides for maximum fines of up to $1.1 million for corporations and $220,000 for individuals, along with potential imprisonment terms. Additionally, any person who knowingly or recklessly makes a false or misleading statement in an advertisement can face penalties under section 45 of the Act, with fines and imprisonment terms commensurate with the severity of the breach. These provisions underscore the importance of compliance with the Code to avoid severe legal repercussions.