The Therapeutic Goods Administration (TGA) recently announced the release of the Therapeutic Goods Advertising Code 2021 (TGA Code) following eighteen months of consultation with stakeholders. Amongst other updates, the TGA Code reduces the number of mandatory statements required to accompany advertisements of therapeutic goods. This article discusses the key changes introduced in the new TGA Code.
What are therapeutic goods?
Therapeutic goods are health-related products used for various reasons including altering bodily processes, managing injuries or illnesses, preventing or testing for pregnancy, and modifying or replacing part of the body. They also include medicines, medical devices, disinfectants and blood products.
Section 3 of the Therapeutic Goods Act 1989(Cth)(Act) defines “therapeutic goods” to mean goods:
“(a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the manufacture of therapeutic goods; or
(iii) for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
(b) included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);
and includes biologicals, medical devices and goods declared to be a therapeutic goods under an order in force under section 7”
(for the full definition, see section 3 of the Act).
Application of the TGA Code to advertising of therapeutic goods
The TGA Code is an essential part of the TGA regulatory framework and sets out the minimum requirements for advertising therapeutic goods to the public.
The new TGA Code came into effect on 1 January 2022; the deadline for advertisers to transition to the new TGA Code is 30 June 2022 and during the transition, advertisers have discretion as to whether they use the old or new TGA Code. From 1 July 2022 all advertising will be assessed against the 2021 TGA Code requirements.
Section 3 of the Act defines an “advertisement” in relation therapeutic goods as making:
“any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
- is on the label of the goods; or
- is on the package in which the goods are contained; or
- is on any material included with the package in which the goods are contained.”
The Act makes it clear that “intention” refers to not what the advertiser intends by releasing the information, but rather what the end viewer thinks the advertiser intended.
What’s new?
The TGA Code replaces the 2018 TGA Advertising Code; in general, the overall regulatory Australian context has remained the same between the new TGA Code and the previous version. The following regulations remain the same including:
- advertising may not refer to serious disease, such as those requiring diagnosis, treatment or supervision by a health practitioner, without TGA approval;
- many therapeutic goods cannot be advertised at all; and
- the TGA requires advertisements of therapeutic goods to promote safe and proper use of goods, not to mislead customers, to encourage informed health care choices and to be consistent with current public health campaigns.
The TGA Code has introduced a number of key changes including:
- amendments to distinguish between therapeutic goods available physically and those only available online, so consumers are warned as part of the advertising of products they are unable to inspect the product physically;
- updates to make it easier to identify specific requirements for advertising medical devices and medicines;
- expansion of the list of permitted product samples that may be offered in, or as, advertising of therapeutic goods, including face marks, rapid antigen tests for COVID-19, gloves, hand sanitiser and certain nicotine products;
- clarification that, testimonials that are either incentive-based or paid, are not allowed to be included in advertisements. This is in contrast to the 2018 version of the code which allowed such advertising as long as the incentive was disclosed;
- expansion around the “safe and proper use” advertising requirements; advertisements that cause undue distress, fear or alarm are prohibited; and
- consolidation of the prohibited representation rules; these rules have been moved to the Therapeutic Goods Regulations 1990(Cth)(Regulations).
The 2018 version contained a number of mandatory statements that advertisers must include when advertising therapeutic goods. The new TGA Code has reduced the number of these mandatory statements, although the following still apply:
- any short form advertisement must include the statement, “always follow the directions for use”.
- advertisements for therapeutic goods that may only be purchased at a pharmacy must include the statement, “ask your pharmacist about this product”.
- advertisements for therapeutic goods that may only be obtained through a health professional must include the statement, “this product is not available for purchase by the general public”.
Takeaways
The new TGA Code provides updates that simplify the overall TGA advertising requirements whilst also ensuring a sound regulatory framework exists. Advertisers should be mindful of the TGA Code updates and ensure adherence to both the Act and the Regulations, keeping in mind prohibited representation rules have been removed from the TGA Code and are now consolidated in the Regulations only. Whilst there is a transition period, advertisers should ensure their advertising complies with the new TGA Code prior to 1 July 2022.
Links and further references
Related articles
Overview of the Therapeutic Goods Advertising Code by the TGA – https://www.tga.gov.au/media-release/new-therapeutic-goods-advertising-code-1-january-2022
Legislation
Therapeutic Goods Act 1989(Cth)
Therapeutic Goods (Charges) Act 1989(Cth)
Therapeutic Goods (Charges) Regulations 2018
Therapeutic Goods (Medical Devices) Regulations 2002(Cth)
Therapeutic Goods Regulations 1990(Cth)
Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021
Further information
If you need advice on the advertising therapeutic goods or compliance with the Therapeutic Goods Advertising Code 2021 contact us for a confidential and obligation free and discussion:
Malcolm Burrows B.Bus.,MBA.,LL.B.,LL.M.,MQLS.
Legal Practice Director
Telephone: (07) 3221 0013 (Preferred)
Mobile: 0419 726 535
e: mburrows@dundaslawyers.com.au
Disclaimer
This article contains general commentary only. You should not rely on the commentary as legal advice. Specific legal advice should be obtained to ascertain how the law applies to your particular circumstances.
