Due to a complex array of legislation, regulations and codes, advertising therapeutic goods in compliance with Australian law can be a difficult (or, at the very least, a time consuming) road for life sciences companies to navigate. Over the past few years, we have seen that when campaigns deal with fast-changing and “unprecedented” circumstances (such as a global pandemic) companies can mis-step, with non-compliance leading to possible reputational damage and regulatory action, including fines imposed by the Therapeutic Goods Administration (TGA) or an industry body, such as Medicines Australia (MA). Indeed, the TGA has noted that the complexity and urgency of advertising enquiries has been increasing in recent years and even major, sophisticated life sciences companies continue to struggle to ensure compliance with Australia’s strict therapeutic goods advertising regime, resulting in significant fines and reputational damage.
In this article, we summarise some of the requirements companies should be aware of when advertising therapeutic goods in Australia. This article will be the first in a series of articles focused on advertising and communicating about therapeutic goods in Australia, with the aim of helping companies understand the different obligations and restrictions applicable to their campaigns, and to minimise regulatory and compliance risks so that life sciences companies can continue to focus their energies on their life-saving and ground-breaking work.
Regulatory framework in Australia
In Australia, the advertising of therapeutic goods is regulated by the TGA pursuant to the Therapeutic Goods Act 1989 (Cth) (TG Act), Therapeutic Goods Regulation 1990 (Cth) (TG Regulations), and Therapeutic Goods Advertising Code 2021 (Cth) (TGA Code). There are also a number of industry codes of practice that contain provisions relating to the advertising of therapeutic goods, including: the MA Code of Conduct (MA Code), which all MA member companies must comply with, and which the TGA, in its marketing approval, requires the promotion of all prescription products to comply with; and, the Medical Technology Association of Australia (MTAA) Code of Practice (MTAA Code), with which all MTAA members must comply.
Advertising prescription medicines (and certain over-the-counter products) directly to consumers is prohibited under the TG Act, with some very limited exceptions. Off-label marketing of therapeutic goods is also prohibited: marketing can only promote products and indications that are included on the Australian Register of Therapeutic Goods (ARTG). In our experience, difficulties can arise for companies in relation to products included on the ARTG with a particular indication where their marketing materials do not exactly reflect that approved indication. If the exact indication is not used, companies should carefully consider whether the use of the product described or depicted in their marketing materials falls squarely within the ARTG-approved indication(s).
In circumstances where advertising to consumers is permitted (e.g. for some over-the-counter products), the form and content of those advertisements are strictly regulated and, in particular, the TGA Code includes an extensive list of statements that must and must not be included.
In addition, companies should be aware of general consumer protections under Australian Consumer Law (ACL), which prohibit companies from engaging in misleading and deceptive conduct or from making false or misleading claims in relation to products, including therapeutic goods.
Finally, companies should also consider whether the Australian Association of National Advertisers (AANA) Code of Ethics applies to their particular campaign, including where the campaign involves use of social media and influencer marketing strategies.
What is regulated as a therapeutic good?
The federal framework regulating advertising of therapeutic goods in Australia only applies to products that are “therapeutic goods”.
In Australia, “therapeutic goods” are defined by the TG Act as:
- products that are, are represented to be, or are likely to be taken to be:
- for therapeutic use; or
- for use as an ingredient or component in the manufacture of therapeutic goods; or
- for use as a container (or part of a container) for therapeutic goods; and
- products for which the sole or principal use is (or ordinarily is):
- a therapeutic use; or
- use as an ingredient or component in the manufacture of therapeutic goods; or
- use as a container (or part of a container) for therapeutic goods.
Pursuant to the definition of “therapeutic use”, therapeutic goods therefore encompass products for use in humans in, or in connection with:
- preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury;
- influencing inhibiting or modifying a physiological process;
- testing the susceptibility of persons to a disease or ailment;
- influencing, controlling or preventing conception; and
- testing for pregnancy.
However, some products that would otherwise fall within the definition of a therapeutic good are designated as “excluded goods”, meaning they are instead regulated as standard consumer products (for more information on excluded goods, see here).
What are the basic requirements for advertising therapeutic goods in Australia?
Advertisements for therapeutic goods in Australia:
- must not contain “prohibited representations” or “restricted representations”;
- must not advertise biologicals (including certain human cell and tissue (HCT) products;
- must not advertise therapeutic goods containing substances listed on Schedule 3 (Pharmacist Only), Schedule 4 (Prescription Only) or Schedule 8 (Controlled Drug) of the Poisons Standard;
- must not be misleading or likely to mislead;
- must not imply in any way that the therapeutic goods are safe, without harm or side-effects, effective in all cases, a guaranteed cure, infallible, unfailing, magical or miraculous;
- must not cause or be likely to cause undue alarm, fear or distress, or suggest that harmful consequences will result from the goods not being used;
- must be accurate, balanced and only contain substantiated information;
- must be consistent with the safe and proper use of the therapeutic goods; and
- must contain relevant “required representations” and “mandatory statements”,
unless prior authorisation has been granted (e.g. with respect to therapeutic goods containing substances listed on Schedule 3, the substance is included in Appendix H of the Poisons Standard).
“Restricted representations” are representations in an advertisement about therapeutic goods that refer to a serious form of a disease, condition, ailment or defect, which includes forms where:
- it is medically accepted that the form requires diagnosis, treatment or supervision by a suitably qualified health professional (unless medically diagnosed and accepted as being suitable for self-treatment and management); or
- there is a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available for the form (including a self-administered test), which requires medical interpretation or follow-up,
but does not include pregnancy (other than pregnancy with a medical, obstetric or surgical complication).
A “prohibited representation” is defined to include several kinds of representations, including, for example, specific representations relating to analgesics, disinfectants, antiseptics, vitamins and mineral supplements, as well as, more generally:
- any representation regarding abortifacient action; and
- any representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or pre-disposition to: neoplastic disease; sexually transmitted diseases; HIV AIDS; hepatitis C virus (HCV); or mental illness.
To obtain authorisation (from the TGA) to make a restricted representation, it must meet the public interest criteria specified in the TGA Code, and to obtain authorisation to make a prohibited representation, it must be necessary for the appropriate use of the therapeutic good or necessary in the interests of public health.
In addition to the numerous prohibitions on representations that can be included in advertisements, the TG Regulations and TGA Code set out an extensive array of statements and representations that must be included in promotional materials. Which representations are required depends on factors such as the particular therapeutic good being advertised and the medium in which the advertisement is published. For example, there are specific and different requirements for medicines containing Schedule 3 substances, complementary medicines, analgesics, vitamins and minerals, sunscreens, and therapeutic goods for weight management.
Advertisements must also comply with rules in the TGA Code regarding advertising to children, making scientific or clinical representations, maintaining consistency with public health campaigns, and limits on the inclusion of endorsements, testimonials, incentives or offers of samples.
As noted above, the promotion of prescription products to the general public is strictly prohibited, with some very limited exceptions. However, “disease state awareness” campaigns are permitted. Such campaigns must not be designed to encourage consumers to request a specific prescription product from their healthcare professional and cannot otherwise be “promotional”.
In our next article in this series, we will consider the definition of “advertisements” and how some campaigns that are intended to be purely educational, or which are simply intended to raise awareness about particular diseases or conditions (rather than relating to therapeutic goods specifically), can find themselves on the wrong side of this definition. For these types of campaigns, ensuring campaign materials are not classified as “advertisements” is essential to reduce regulatory and compliance risks, including TGA enforcement actions and complaints by competitors, healthcare professionals or members of the public to the TGA, AANA, Australian Competition and Consumer Commission (ACCC), or industry bodies such as MA and the MTAA.