The Therapeutic Goods Advertising Code (Code) is the latest legislative instrument to be implemented as part of the Australian Government's response to the Review of Medicines and Medical Devices Regulation first released on 15 September 2016.
What is the Code?
The Code is the key legislative instrument underpinning the advertisement of therapeutic goods in Australia. Among other things, it sets out the minimum requirements that advertisers must follow. The Code complements the advertising provisions set out in the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990.
What is an advertisement?
To assist advertisers, the TGA have published Australian Regulatory Guidelines for Advertising Therapeutic Goods to clarify activities likely to constitute advertising.
In making this decision, the following factors will be considered:
- the context in which the information or activity occurs;
- the audience and key take-out messages of the material; and
- use of non-verbal and unwritten messages, such as pictures.
Unsolicited or unbalanced information is likely to be considered promotional, as will the use of superlatives, adjectives or emotive statements such as 'the best' or 'changed my life'.
What are the key changes?
The new 2018 Code brings a number of changes. Key changes include:
- clarification of what advertisements must contain for goods that are not available for physical examination before purchase i.e. internet advertising;
- ·new required warning statements to be displayed or communicated for Schedule 3 (Pharmacist Only) medicines;
- clarification that advertising must not be primarily directed to children under the age of 12 years;
- clarification of the requirements for testimonials; and
- a new complaints handling process.
When will it come into effect?
Although the new 2018 Code has already been registered, it will not take effect until 1 January 2019. This will give time for companies to familiarise themselves with the new Code and make any necessary changes to promotional materials (including on the internet).
The new Code will impact advertisements that require pre-approval. These include advertisements that appear in magazines, newspapers, TV, radio, billboard or cinematograph films. Applications for pre-approval lodged on or after 1 January 2019 will be assessed against the new 2018 Code. Applications lodged prior to this date will be assessed against the 2015 Code.
Companies should use the next six months to review their current advertisements to ensure that any advertising/ promotion of their therapeutic goods after 1 January 2019 will be compliant with the new 2018 Code.
Dentons is the world's first polycentric global law firm. A top 20 firm on the Acritas 2015 Global Elite Brand Index, the Firm is committed to challenging the status quo in delivering consistent and uncompromising quality and value in new and inventive ways. Driven to provide clients a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. Now the world's largest law firm, Dentons' global team builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size in more than 125 locations serving 50-plus countries. www.dentons.com.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.