The TGA have published a new Advertising Code (2021) from commencement on 1 January 2022 with a 6 month transition period ending on 30 June 2022. Below is an overview provided by Complimentary Medicines Australia.
Overall changes
- Definitions are made easier to access – The definitions for ‘advertise’, ‘health practitioner’, ‘health professional’, ‘indications’ and ‘intended purpose’ from the Therapeutic Goods Act 1989 and associated regulations are reproduced in the Code.
- New (returned) prohibition on ‘fear-mongering’ in advertising
– A new provision has been added to prohibit any advertisement about a therapeutic good that will cause, or be likely to cause, undue alarm, fear or distress. This provision reinstates the requirement from the 2015 version of the Code despite the removal of this clause in from the 2018 Code in response to MMDR recommendations to make the Code more objective.
– In relation to restricted representations (public interest criteria), the new 2021 Ad Code includes language referencing to ‘exploit’ and ‘discourage’ as per the below excerpts:
“…whether the representation would be likely to exploit, or take advantage of, vulnerable consumers,”; and
“…whether the representation would be likely to delay or discourage consumers from seeking timely medical attention”.
Testimonials
- Paid testimonials and incentivising consumers to provide testimonials cannot be included in advertisements. Testimonials from people involved in the sale of the goods are not permitted. This means that paid testimonials may need removal from existing ads.
– The TGA have specified that paid testimonials by influencers, direct sellers, and others are not permitted (however direct sellers and influencers are still able to discuss the uses (label indications) of a product. CMA is continuing to seek ways to return testimonials.
- Testimonials and/or endorsements which imply the testimonial/endorsement provider has health expertise or are former health professionals are not permitted
Mandatory statements and warnings
- The mandatory warning statements have been significantly simplified.
- The requirement for a mandatory ‘if symptoms persist’ statement to be included in certain advertising has been removed. This is because seeking health professional advice if symptoms persist is a post purchase behaviour and not a part of the purchasing decision.
Note: A symptoms statement may still be required on medicine labelling as a result of other regulatory requirements (such as the Permissible Indications Determination).
– The mandatory statement has been made the same for all medicine ads: “ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE”
- The new Code has also simplified by distinguishing between those products that can be viewed by consumers prior to purchase and those that cannot. There will be no requirement for health warnings for those advertisements where the product can be inspected before purchase. Subsequently, the 2018 Code’s Schedule 1 of health warnings has been removed from the 2021 Code.
- For advertising of a product that has health warnings and the advertisement facilitates the purchase of the product those warnings will be required in the advertisement:
– Due to the removal of Schedule 1 of health warnings, most of these advertisements will require additional health warnings to be added, including any that meet the new simplified definition of a health warning.
– In these advertisements for products not able to be physically inspected by a consumer before the purchase or other supply, a list of the health warnings may be provided, or alternatively, a link to health warnings for a product is now permitted to be provided.
Samples
– The Code clarifies that advertisements ‘must not contain or consist of a sample, or an offer of a sample’ (the 2018 Code only specified ‘must not contain an offer of a sample’) and makes other clarifications about requirements relating those samples which are specifically permitted by the Code.
– The New Code includes additional samples that can be offered such hand sanitisers, oral hygiene products; oral rehydration products; and wound care dressings for superficial wounds, including first aid items and antiseptics. The TGA will provide guidance on the process for applying for additions to the list of permitted samples including the assessment criteria that will be used.
Incentives
– The code clarifies that commissions cannot be given to retail assistants who are not health professionals “An advertisement about therapeutic goods must not offer any personal incentive or commission to a pharmacy assistant, or any retail salesperson who is not a health professional, in exchange for recommending or supplying the goods”.
Goods that may be advertised to children
– The new Code has been updated to include a number of additions including hand sanitisers; oral hygiene products; and oral rehydration products