TGA Releases New Advertising Guidance
The Therapeutic Goods Administration (TGA) has issued new guidance material setting out requirements on businesses that advertise medical devices direct to the public.
Key Issues For The Dental Industry —
Although most dental products are advertised and distributed to healthcare professionals, it is not uncommon for some (such as orthodontic appliances) to be advertised by product manufacturers and suppliers directly to the public. Such businesses need to be aware of the TGA’s requirements associated with direct to public advertising of medicines and medical devices.
Most dental products are defined as ‘medical devices’ under the Therapeutic Goods Act 1989 (Cth) and as such are not considered to be consumer products. The Australian Government’s position is that advertising of therapeutic goods requires a higher ethical standard than may apply for ordinary consumer goods. Consumers rely on therapeutic goods for their health. Determining the appropriateness of a therapeutic good can be difficult for a consumer and it is important that promotional material is truthful, balanced, and not misleading.
The TGA has set, in concert with the Australian Dental Industry Association (ADIA) and other stakeholders in the medical devices sector, a clear framework for the advertising of medical devices to the public. This is set out in the following documents:
|Therapeutic Goods Administration Documentation —|
The TGA framework states that advertising should give adequate information on the risks and cautions around a product and recommend seeking advice from a health professional where appropriate. As a result, there is specific legislation that applies to the advertising of therapeutic goods to consumers (over and above Australian Consumer Law, which regulates advertising generally) and applies to therapeutic goods through the requirements under the Therapeutic Goods Act 1989 (Cth) and subordinate regulation. The regulation of advertising reflects the importance of consumers being properly informed so that they can select treatment options appropriately for use in their own and their family’s healthcare.
When advertising therapeutic goods to the public, the dental industry must comply with the Therapeutic Goods Advertising Code (No 2) 2018 (the Code), which is the cornerstone of the therapeutic goods advertsing regulatory framework. Not all therapeutic goods are allowed to be advertised to the public including biologicals, goods containing a Schedule 4 or Schedule 8 of the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard), and goods containing a Schedule 3 substance not included in Appendix 8 of the Poisons Standard. More information is available on these restrictions and others in: Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG).
The broad framework associated with advertising dental products to consumers is not new; however, it has been updated. Further, compliance with the Complying with the Therapeutic Goods Advertising Code (No. 2) 2018 is a requirement of the ADIA Code Of Practice.
Further information —
For further information on matters relating to the TGA Advertising Guidance please send an email to [email protected] or telephone 1300 943 094. To keep up to date with all that is happening in Australia’s dental industry following ADIA on Twitter at @AusDental and on Facebook at www.facebook.com/dental.industry.
Currency & Disclaimer —
This update was issued on 8 November 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
Article Credit: ADIA – https://www.adia.org.au/