How healthy are your advertising practices Updates to Therapeutic Goods Advertising Code
30 March 2022
What you need to know
- Extensive changes to the Therapeutic Goods Advertising Code came into effect on 1 January 2022 (the 2021 Code).
- There will be a 6 month transition period during which advertisers may elect to be compliant with either the previous advertising code (the 2018 Code) or the 2021 Code.
- All advertisers must be compliant with the 2021 Code by 30 June 2022.
What you need to do
- Ensure that your business understands the amendments introduced by the 2021 Code and commences making changes to their advertising practices.
- Take all necessary steps to make sure your business is fully compliant with the 2021 Code by 30 June 2022.
What are Therapeutic Goods?
Therapeutic goods are products for use by people in connection with their health, whether it be to prevent, diagnose, alleviate or cure diseases, to modify or influence a physiological process or to test the susceptibility of a person to a disease or ailment. The definition of a therapeutic good is incredibly broad and can include products which make claims to aid or assist with health but would not ordinarily be considered to be medicines (for example, food or cosmetics).
There are three main categories of therapeutic goods:
- Medicines (eg, prescription and over-the-counter medicine);
- Biologicals (eg, products that are made from or contain human cells or tissues); and
- Medical devices (eg, pacemakers, bandages, COVID-19 rapid antigen tests).
The advertising of therapeutic goods is regulated by the Therapeutic Goods Act 1989 (Cth) (the Act) and is administered by the Therapeutic Goods Administrator (TGA). Each of the States and Territories has its own poisons and therapeutic goods legislation which addresses where and how such goods can be sold and their labels.
Why do therapeutic goods need an advertising code?
Given the health implications of therapeutic goods, and the difficulty consumers can have in determining the appropriateness of a therapeutic good for their circumstances, strict advertising regulations are necessary to ensure consumers receive accurate information about the quality, safety and efficacy of therapeutic goods.
The Therapeutic Goods Advertising Code sets out the prohibitions and requirements for advertising therapeutic goods to the public to ensure only credible information is presented in advertisements about therapeutic goods and to enable consumers to make informed decisions regarding the suitability of goods for their health needs.
What hasn't changed?
The objectives of the 2021 Code reflect those that were present in the 2018 Code, being to:
- promote the safe and proper use of therapeutic goods by minimising misuse, overuse or underuse;
- ensure that advertisements are ethical and do not mislead or deceive consumers about the performance of therapeutic goods;
- support consumers in making informed healthcare choices; and
- ensure that the advertising of therapeutic goods is consistent with public health campaigns.
The general requirements of the 2021 Code are also largely consistent:
- the advertising of therapeutic goods that contain substances included in Schedule 3 (not including ingredients that appear in Appendix H of the Poisons Standard), 4 or 8 of the Poison Standard are prohibited subject to a very limited right for the publication of price lists by pharmacies, their agents or certain medical practitioners;
- advertisements about therapeutic goods must be accurate, balanced, not misleading and must only contain information that has been substantiated by the advertiser; and
- advertisements about therapeutic goods must not contain any statement or representation that the goods are safe or without harm or side-effects or are guaranteed to be effective or infallible.
So what is new?
The key changes to the 2021 Code include:
- Simplified structure: A new structure means that the general requirements that apply to advertising of all therapeutic goods is separate to the specific requirements applicable to the advertising of particular medicines, medical devices and other therapeutic goods. This makes the 2021 Code much more user friendly and easy to navigate.
- Simplification of mandatory statement requirements: The number of mandatory statements have been reduced and simplified. Where a product will be physically inspected by a customer before purchase, fewer statements are required. Additional mandatory statements are required where a product is not able to be examined before purchase (for example, online purchases).
- Expansion of safe and proper use provisions: A prohibition against advertisements of therapeutic goods that cause, or are likely to cause, undue alarm, fear or distress has been introduced to prevent advertisers from leveraging and benefiting from such tactics.
- Clarification of endorsements and testimonials: The requirements have been amended to clarify that an advertisement about therapeutic goods cannot contain an endorsement or testimonial from:
- a person who receives a payment or incentive to provide the endorsement or testimonial (this is in contrast to the 2018 Code which permitted such advertisements provided that the payment was disclosed); or
- a person engaged in the production, marketing or supply of the goods or a member of that persons immediate family (unless this relationship is disclosed in the advertisement); or
- a person who is a current or former health professional, health practitioners or someone representing themselves as being such a person.
- Offering of samples and advertising to children: The list of therapeutic goods that may be offered as samples in advertisements has been expanded from 4 categories of products to 14 categories by the 2021 Code. The list of therapeutic goods that may be advertised to children over 12 has also been expanded.
- Prohibited representations: The prohibited representations set out in s 30 of the 2018 Code (e.g. representations about cancer, mental illness, STIs) have been moved without alteration from the Code into the Therapeutic Goods Regulations 1990 (Cth).
What should your business be doing?
From 1 July 2022, advertisers must ensure their practices comply with the requirements of the 2021 Code. Failure to do so may result in an offence. Depending on the nature of the offence committed, the civil penalties can be as much as $11 million for a corporation and a criminal offence can result in imprisonment as well as a significant fine.
Given the severity of these penalties, it is critical that advertisers familiarise themselves with the 2021 Code requirements. Specifically, advertisers should:
- ensure that any mandatory statements used in advertisements of therapeutic goods comply with the updated wording set out in the 2021 Code;
- ensure that advertisements do not contain endorsements or testimonials that are linked to a payment or incentive or otherwise violate the 2021 Code;
- identify if there are any opportunities to offer samples of goods that they may not have been permitted to offer under the 2018 Code; and
- perform a general review of their advertising practices to confirm that they are compliant.
Authors: Nina Fitzgerald, Partner and Lachlan Wright, Lawyer.
