The TGA has issued an updated Therapeutic Goods Advertising Code (New Code). The New Code regulates advertising of therapeutic goods to consumers. Only certain therapeutic goods can be advertised to the public. The New Code seeks to ensure that permitted advertising provides consumers with accurate and balanced information concerning the quality, safety and efficacy of the therapeutic goods.
There are a broad range of potential consequences for failing to adhere to the New Code. Although most typically, compliance issues are addressed by the TGA through regulatory measures, in serious cases, there is a possibility of significant criminal sanctions. In addition to this, non-compliance can lead to undesired and distracting media attention, and divert business resources that can be better utilised.
Australian rules permit advertising of most medical devices and medicines available for over-the-counter sale. Prescription-only and some pharmacist only medicines cannot be advertised (beyond the provision of limited price information).
The New Code commenced on 1 January 2022. However, until 30 June 2022, advertisers may continue to apply the requirements set out in the previous version of the advertising code (Prior Code).
This transition period provides advertisers with the opportunity to review their current and proposed marketing to ensure compliance with the changes introduced by the New Code.
Key changes relate to:
- Testimonials and endorsements. The New Code seeks to clarify the previous requirement of the Prior Code, such that testimonials cannot be included in advertisements if the testimonial is made by a person who is “engaged in the production, marketing or supply of the goods”, or a member of that person’s immediate family (unless the advertisement discloses they are a family member of the person).
This is intended to restrict advertisements from including testimonials from any person who will receive any form of consideration (whether a financial incentive, gift or other reward) for making the testimonial, including social media “influencers” and direct sellers. There is however no general prohibition on advertisements featuring endorsements from such people. Advertisements including endorsements from people engaged in the production, marketing or supply of the goods should be carefully considered to ensure they could not be construed as testimonials.
Public consultation in the lead up to the introduction of the New Code sought more permissive rules around testimonials, especially for direct sellers, but they were not adopted by the TGA. The TGA’s approach is directed to ensuring any testimonials used in advertising are genuine and given without ulterior commercial motivation. This objective aligns with more general regulation of advertisements seeking to ensure consumers are not mislead by #sponcon. See here for our recent article on this subject.
Additionally, advertisements cannot include testimonials or endorsements by various persons and groups involved in government, healthcare and health advocacy (except in some case with additional disclosure). The New Code clarifies that the prohibited persons includes current and former health professionals, health practitioners and those representing themselves as being such a person.
- Mandatory statements. The New Code seeks to simplify the mandatory statements that advertisements must contain. Each mandatory statement must be prominently displayed or communicated with the advertisement.
The New Code specifies mandatory statements for therapeutic goods that are only available from pharmacists, for therapeutic goods that are only available for supply through a health professional, and for therapeutic goods that are available for direct supply to consumers. The requirements in respect of therapeutic goods available for direct supply to consumers depend on whether those goods are medicines, medical devices or other therapeutic goods, and also, whether the consumer will have the opportunity to inspect the goods prior to supply.
The New Code also includes specific statements that must be included when advertising analgesics, complementary medicines, sunscreens, and therapeutic goods relating to weight management.
- Other information to be included in advertisements. Certain information in addition to mandatory statements also needs to be included in various advertisements. The precise requirements vary depending on the type of therapeutic good and, in some cases, the form of the advertisement. Some requirements under the Prior Code (for example, relating to symptoms statements) have been changed, and others removed.
- Samples. The New Code expressly states that the provisions relating to samples applies to both the sample itself and the offer of a sample an advertisement. This clarifies the position from the Prior Code, which only covered advertisements offering a sample.
The New Code provides a list of the types of therapeutic goods that may be given as samples. The New Code identifies additional therapeutic goods that may be given as samples including hand sanitisers, face masks and gloves.
Anyone promoting, distributing or selling therapeutic goods to members of the general public should review their current and planned advertising and other promotional materials against the New Code to ensure continued compliance. Depending on the type of product and the sales model, it is important to remember that these materials can include a broad range of messaging, such as verbal information provided by sales people over the phone or product descriptions provided online.
Existing physical materials (e.g., printed advertisements and sample packaging) should be reviewed for compliance, and if non-compliant, consideration should be given to whether stock is likely to be distributed before or after 1 July 2022. Where necessary, steps should be taken to prevent further distribution or use of advertising materials that do not comply with the New Code after 30 June 2022.