TGA releases updated advertising code: Key takeaways for healthcare teams

Wednesday 30 January 2019

TGA releases updated advertising code: Key takeaways for healthcare teams

Healthcare TGA codeAdvertisers working with healthcare clients need to make sure their ad is compliant at all times, and with the recent changes to the advertising code now in effect (from January 1, 2019) now’s the perfect time to ensure your teams and clients are familiarising themselves with the rules that apply. From pre-approvals, to product claims, to health warnings, here are the biggest changes that may affect you.

By Mike Cocks

By law, all advertising of therapeutic goods directed to consumers must comply with the Therapeutic Goods Advertising Code. On 1 January 2019, the Therapeutic Goods Advertising Code (No. 2) took effect.

While the TGA has published guidance to help advertisers comply with this new Code, a summary of key changes is provided below for Comms Council members who are, or plan on, working with clients in the healthcare space.
Overall Governance and Implementation
This is now to be carried out by the TGA alone.
The new TGACC, renamed the Therapeutic Goods Advertising Consultative Committee, on which the Communications Council is represented, is as the name suggests, designed to provide on-going consultation to the TGA from all major stakeholders on therapeutic goods advertising/communications to Consumers. TGA have stressed that one of the key roles of the new TGACC will be in helping the TGA with priority setting.
These are now included in the code with details of special requirements inc health warnings.
Health Warnings
These have been spelt out and clarified and now include specific warnings for products containing particular active ingredients in Schedule 1 of the code.
There is also a clearer definition of what is meant by ‘prominently displayed or communicated’.
For S3s – pharmacist only products - which following the change in policy, are likely to include more which are permitted to advertise Direct to Consumers (DTC), a special warning is now mandatory  - ‘Ask your Pharmacist – they must decide if this product is right for you’.
Scientific Evidence
This is a key tool in healthcare advertising but must be ‘expressed appropriately as befits the actual scientific/clinical evidence available. It must be clearly communicated and able to be understood by the audience to whom it is directed and must be consistent with the body of scientific/clinical evidence applicable to the advertised therapeutic goods. It must also clearly identify any study so that consumers can access them’.
Endorsements  & Testimonials
Again there is now greater clarity as to what the differences are and what they may claim, together with what declarations must be made for each of them.
Weight Management Products & Claims
These products have  been more clearly defined and what they can and cannot claim and how they must ‘balance the claims with the need for a healthy energy-controlled diet and physical activity.
We are reminded that these must be depicted as only one part of sun protection and must include prominently displayed statements to effect that prolonged high-risk sun exposure should be avoided and frequent re-application of the sunscreen is  required for effective sun protection.
Transition Period
Effectively any advertising pre-approved before Dec 31 2018 will have been approved under the previous 2015 code and as such will have a 2 year life from the date of its pre-approval. Any material approved after Dec 31 2018 will need to comply with the new code – TGAC No2 2018.
This pre-approval system for material in mainstream media is currently scheduled to remain in force until june 2020.
Further Education
TGA have undertaken to provide a number of 2-sided Fact Sheets on most of the above, together with examples, which should facilitate understanding  the revised code’s changes and help communicators on compliance with it. We will advise when these become available.
There is also a 75 page guideline document available from TGA’s advertising Hub which may or may not be of assistance.
It is also planned to run educational seminars for members. You will be advised of details in due course..

Mike Cocks is a communications consultant and member of the Communications Council Healthcare Committee.


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