Australia: A tighter prescription for advertisers: The Therapeutic Goods Advertising Code (No.2) 2018

Last Updated: 26 November 2018
Article by Matthew Wilson

Any business that advertises non-prescription therapeutic goods to consumers must comply with the requirements of the Therapeutic Goods Advertising Code. At a high level, the Code regulates:

  • what you may say and what you must say about therapeutic goods in advertisements; and
  • who you are allowed to advertise therapeutic goods to (eg. prohibitions/restrictions on marketing certain products to children).

The Therapeutic Goods Advertising Code 2015 (Old Code) setting out these requirements is about to be replaced by the New Code and there are various changes under the New Code that companies should consider.

When does the New Code come into effect?

The New Code (except for Part 4 of Schedule 1) will come into effect on 1 January 2019. Part 4 of Schedule 1 dealing with mandatory statements for ingredients in registered or listed medicines will commence on 1 September 2020.

What changes under the New Code?

Some of the more interesting and important changes under the New Code include:

  • the requirement to substantiate all information presented in advertisements before they occur;
  • changes to mandatory statements for pharmacist-only medicines;
  • new provisions relating to goods that are not available for physical examination before purchase;
  • new requirements relating to public health campaigns;
  • additional requirements about advertising weight management products; and
  • changes to the restrictions on advertising therapeutic goods primarily to children.

Substantiating information

Under the New Code, all information presented in advertising must be substantiated before the advertising occurs. This imposes a higher standard on advertisers compared to the Old Code which allowed for some information to only have to be capable of substantiation in certain circumstances. Advertisers will now have to be able to show that they took steps to ensure the accuracy of all information before advertising.

Pharmacist-only medicines

One of the more interesting changes under the New Code is its acknowledgement of the role of the pharmacist in the decision-making process regarding the use of certain 'over the counter' therapeutic goods (namely the ones containing substances listed in Schedule 3 of the Poisons Standard (Pharmacist-only Medicines)).

Under the Old Code, advertisements for Pharmacist-only Medicines were required to contain the statement 'YOUR PHARMACISTS ADVICE IS REQUIRED'. Under the New Code, advertisements for Pharmacist-only Medicines are required to include the statement 'ASK YOUR PHARMACIST – THEY MUST DECIDE IF THIS PRODUCT IS RIGHT FOR YOU'.

This seems to place the decision-making power and responsibility of assessing whether Pharmacist-only Medicines should be used in the treatment of a patient's condition in the hands of the pharmacist, as opposed to having them perform an advisory role. While this may not affect advertisers, it does appear to reflect the changing role of pharmacists in the treatment of certain illnesses (rightly or wrongly).

Therapeutic goods that are not available for physical examination before purchase

Section 12 of the New Code includes various new requirements that apply to the advertisement of therapeutic goods to consumers where the consumer does not get the opportunity to examine the relevant goods prior to (or at the time of) purchase (eg. goods sold online or via mail order catalogues). Essentially the New Code incorporates and adds to the new information and labelling requirements under the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines (New Labelling Order).

Under the New Code, advertisements for medicines sold in this manner must display similar information to that required under the New Labelling Order. That is, the name of the good, the name of the dosage form, the quantity of the good, the indications of the good and the list of its ingredients, etc., as well as any relevant mandatory statements which differ depending on whether a health warning applies (eg. ALWAYS READ THE LABEL). Similarly, new information requirements (and mandatory statement requirements) also apply for advertisements for medical devices and other therapeutic goods (that are not medicines) that are sold in this manner.

Public health campaigns

The New Code requires advertisers to ensure that their advertisements are consistent with public health campaigns (see section 21 of the New Code).

This obliges advertisers to be familiar with all public health campaigns relevant to their products and ensure their advertising does not contradict them.

Sunscreens are one example of the type of product likely to be impacted by this requirement (eg. government campaigns in relation to skin cancer and sun protection).

Weight management products

Section 26 of the New Code prevents advertisers of weight management products from:

  • making claims that include any reference or depiction suggesting the product will correct or reverse the effects of overeating or drinking; or
  • using images of individuals such as 'before and after' pictures, testimonials or statistics about individuals, in an advertisement unless the results achieved by those individuals from the use of those goods would be expected to be achieved on average by users of the goods.

Advertising to children

The New Code prohibits advertisers from directing advertisements primarily to children under 12. Further, advertising may only be directed primarily to children over 12 if the product is listed in Schedule 2 of the New Code.

This imposes a higher standard on advertisers by completely prohibiting primary advertising to children under 12. Although the Old Code prohibited directing advertising to children under 18, some goods (those listed in Appendix 5 of the Old Code) were exempt and could potentially be primarily advertised to all children, including those under 12.

Penalties for failing to comply with the New Code under the Therapeutic Goods Act 1989 (Cth) (TGA Act)

Failure to comply with the New Code could result in:

  • criminal penalties such as fines of up to $840,000 and imprisonment for up to 5 years (for example see sections 42DL and 42DM of the TGA Act); and
  • civil penalties of up to $1,050,000 for individuals and up to $10,500,000 for companies (for example see sections 42DLB and 42DMA of the TGA Act).

Take home message

The New Code places various new requirements on advertisers of non-prescription therapeutic goods to consumers. With the imminent commencement of the New Code, companies who advertise therapeutic goods to consumers should audit their marketing material and approval procedures to ensure compliance.

If you get it wrong, the penalties could be substantial.

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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions