Companies operating in the life sciences industry play a vital role in raising awareness of diseases and other medical conditions, helping people to identify symptoms, seek medical advice, and understand options for management and treatment. However, it can be incredibly difficult for companies in Australia to navigate the fine line between permissible educational campaigns (including “disease state awareness” campaigns), on the one hand, and the unlawful promotion of therapeutic goods, on the other.
The framework regulating the advertisement of therapeutic goods (which we discussed in our recent article) is a hot topic in Australia at the moment. In the past, there has been controversy regarding the Therapeutic Goods Administration’s (TGA) approach to enforcement, with several industry publications covering various TGA enforcement actions.
In this article, we discuss the definition of an “advertisement” under the Therapeutic Goods Act 1989 (Cth) (TG Act) and outline some of the legal and compliance considerations companies should take into account when planning a disease state awareness campaign to minimise associated risks.
What is an advertisement?
As you would expect, the regulatory framework governing the advertisement of therapeutic goods in Australia applies to all “advertisements” relating to “therapeutic goods”. We discussed the definition of therapeutic goods in our most recent article, but it is also important to understand whether a company’s campaign materials might be considered an advertisement despite being intended by that company only for educational purposes.
An advertisement, for the purposes of the TG Act is 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 product label, packaging, or any material included with the product packaging.
When assessing marketing or other informational materials for compliance with the TG Act, companies should consider whether a reasonable consumer would consider the materials to be promoting the use or supply of the product. Materials that contain unbalanced information that emphasises positive product attributes or use descriptive adjectives and emotive statements are likely to be considered promotional by the TGA.
Depending on the context, material that constitutes a factual and balanced statement about a therapeutic good may not be considered advertising under the TG Act. For example, articles in medical journals or genuine news stories are generally not captured by the restrictions on advertising therapeutic goods to the public. However, there can sometimes be a fine line between what is and is not considered to be promotional material, including where companies conduct disease state awareness campaigns not intended to promote therapeutic goods.
Furthermore, where companies provide disease education information in conjunction with promotional materials for therapeutic goods, the materials are taken collectively to be an advertisement subject to the provisions of the TG Act, and associated regulations and codes.
When is a disease state awareness campaign likely to be considered promotional?
Disease state awareness campaigns can include a wide variety of media and methods to raise awareness of a disease or condition (e.g. seminars, videos shown on TV, websites, flyers or downloadable materials, or in-person workshops and educational courses).
While the TGA recognises that disease state awareness campaigns “can be a valuable source of information for Australian consumers”, the TGA has previously taken issue with disease state awareness campaigns that refer to therapeutic goods and, in particular, prescription medicines (even where a brand name is not specified). Where a campaign links a disease state with therapeutic goods (e.g. pharmaceutical products or medical devices), there is a risk the TGA will consider the reference to the therapeutic good to be promotional. In such circumstances, the campaign would meet the definition of “advertise” under section 3 of the TG Act even where the company had no intention to advertise the relevant product(s).
This becomes problematic for companies because advertisements for therapeutic goods must adhere to a variety of strict requirements, including those discussed in our previous article (e.g. if considered to be an advertisement, campaign materials would be prohibited from referring to “serious forms” of a disease without prior TGA authorisation).
Moreover, previous TGA enforcement actions and TGA guidance indicate that where a campaign refers to a range of treatment options available for a disease, the campaign will be considered to be an advertisement if the information in the campaign materials is deemed “likely to encourage consumers to seek to obtain a particular good, or seek a prescription for a particular medicine”.
Companies should be especially careful in circumstances where there are limited treatment options. In such cases, even a simple reference to “treatment(s)” for the relevant disease could be deemed promotional because there are only one or two options for treatment, thus drawing attention to a particular therapeutic good even where the brand or active ingredient is not named.
Further, where a class of therapeutic goods is referred to (e.g. a statement referring broadly to “pain medication”), it is important for companies to consider whether that class includes therapeutic goods that fall within any prohibited category (e.g. prescription products, biologicals or products included on Schedule 3 but not included in Appendix H) as this would increase the overall risk profile of the campaign were it considered to be advertising by the TGA.
What is the position under the Medicines Australia Code of Conduct?
Sponsors of prescription medicines must comply with the Medicines Australia (MA) Code of Conduct (MA Code) in relation to the promotion of prescription medicines. Like the TGA, MA acknowledges the importance of disease statement awareness and educational campaigns, but requires companies to comply with the following MA Code requirements:
- The purpose of the information presented must be educational and should encourage patients to seek further information from an appropriate healthcare professional;
- Campaign materials may include descriptions of a therapeutic category, including classes, but must not reference a specific prescription product;
- Information should be presented in a comprehensive, balanced and fair manner without unduly emphasising particular treatment options or a need to seek treatment;
- The materials must focus on the disease/condition, and its recognition, not on the available treatment options, and it should be clearly stated that the appropriate treatment for a patient is to be decided by their healthcare professional; and
- The campaign materials should not cause unnecessary alarm or misunderstanding, and should not stimulate demand for a prescription medicine.
How can companies avoid educational materials being considered advertisements?
Companies should give detailed consideration to the precise language and content of each aspect of their disease state awareness or other educational campaign materials from a legal and compliance perspective. The change of a single word or image could drastically change the risk profile for a campaign, taking it from a lawful educational campaign to an unlawful promotion of therapeutic goods.
In particular, companies should ensure only accurate, factual, scientifically valid, and balanced information is included in campaign materials, and should consider whether a person viewing the campaign would be led to think about, and/or encouraged to seek out, a particular therapeutic good. Furthermore, the inclusion of testimonials or endorsements relating to a specific therapeutic good (or links to such statements) will make the campaign promotional in nature.
Based on recent TGA publications and past TGA enforcement actions, it appears that the TGA is concerned that organisations that have a commercial interest in manufacturing, selling or supplying therapeutic goods “are more likely to be taken to be advertising therapeutic goods because of an actual or perceived inability … to provide unbiased, factual and non-promotional information” (see here). The nature and purpose of the organisation undertaking a disease state awareness campaign therefore contributes to whether the TGA will find that “reasonable consumers” are likely to view the campaign as an advertisement for therapeutic goods. As a result, life sciences companies should be extra cautious when planning and drafting campaign materials in the current environment.
Later articles in this series will discuss the advertisement of medical devices, and the penalties applicable if a company’s educational materials are deemed to be advertisements, including the TGA’s approach to compliance and enforcement actions, and the MA and Medical Technology Association of Australia (MTAA) complaints processes.