INSIGHT

TGA guidance on the promotion of medicinal cannabis

By Sarah Matheson, Ric Morgan, Tess Kirkinis
Consumer law Franchising Health Intellectual Property Media, Advertising & Marketing

In brief 4 min read

The Therapeutic Goods Administration (TGA) has issued guidance on advertising to the public for businesses involved with medicinal cannabis products and therapies. Along with advertising restrictions, these guidelines may impact the use of cannabis-related trade marks incorporated in business names and branding despite such trade marks being registerable in Australia. Cannabis businesses should carefully navigate this tension and pay close attention to the TGA's guidance to avoid the material risk of civil and criminal penalties arising from non-compliance.

Key takeaways

  • The TGA may apply civil and criminal penalties, or may cancel a business's medicinal cannabis licence, as a result of non-compliance.
  • Advertising will be banned if it uses a statement, pictorial, representation or design that promotes the use or supply of medicinal cannabis.
  • Businesses must not refer to medicinal cannabis in their company, business or trading names, or in any product name, or use any image that is likely to draw the consumer's mind to medicinal cannabis.
  • Investors should consider whether any cannabis business in which they propose to invest is compliant with these TGA marketing restrictions.

Who does this affect?

Businesses involved with medicinal cannabis products and therapies, including sponsors, manufacturers, importers, pharmacists, health professionals and marketers, need to know about the advertising guidance recently released by the TGA (the TGA Guidelines). The TGA Guidelines have been made in accordance with the Therapeutic Goods Act 1989 (the TG Act) and the Therapeutic Goods Advertising Code (No 2) 2018 (the Code).

Advertising restrictions

The TGA Guidelines remind stakeholders that because of the general restrictions applying to prescription medicines, advertising medicinal cannabis products to the public is prohibited under the TG Act, including:

  • medicinal cannabis that is included in the Australian Register of Therapeutic Goods (ARTG) as a prescription medicine (see section 42DL(10)); and
  • medicinal cannabis which is not included in the ARTG and which can only be accessed through the special access pathways, including the Special Access Scheme and Authorised Prescriber Scheme and which are not otherwise subject to an exemption, approval or authority (see section 42DL(2)).

The TGA may apply civil and criminal penalties, or may cancel a business's medicinal cannabis licence, as a result of non-compliance.

What types of advertising activities are prohibited?

The TG Act uses a broad concept of advertising that includes any statement, pictorial, representation or design that is intended, whether directly or indirectly, to promote use or supply of therapeutic goods. The TGA Guidelines clarify what advertising activities the TGA considers promotional and that consequently would be prohibited in relation to medicinal cannabis. These include:

  • Use of a statement, pictorial, representation or design that promotes the use or supply of medicinal cannabis. Such information will be considered promotional where it is not factual, balanced or omits important information such as side effects or the paucity of clinical evidence in relation to the therapeutic benefits of medicinal cannabis.
  • Promotion of a health service by making reference to medicinal cannabis. The ultimate question is whether the reference promotes the use or supply of medicinal cannabis from the end viewer's point of view, regardless of the intention of the advertiser. The TGA Guidelines provide a series of useful and specific examples to assist in assessing this.

Navigating TGA requirements and using cannabis-related trade marks

While it is possible to promote health services involving medicinal cannabis, such promotion must avoid any express or implied reference to medicinal cannabis. Businesses must not refer to medicinal cannabis in their company, business or trading names, or in any product name, or use any image that is likely to draw the consumer's mind to medicinal cannabis. Similarly, colloquial names, abbreviations or acronyms must not refer to medicinal cannabis. For example, the TGA considers that a clinic named 'Far East Med Can Clinic', which offers treatment of pain associated with musculoskeletal disease, would be at risk of contravening the TG Act as a consumer would consider that this clinic uses medicinal cannabis as part of its treatment service.

While these restrictions mean it is likely that any trade mark or business name that references cannabis cannot be used by a business in promoting its health services, there is no restriction on the registrability of such trade marks or business names. Relevantly, a significant number of cannabis-related trade marks (including logos depicting the cannabis plant) have been registered in the last three years.

Accordingly, businesses involved in the supply of medicinal cannabis or in providing health services involving the use of medicinal cannabis should carefully choose what trade marks and business names they adopt, and at an early stage. This will avoid the risk that the use of any chosen trade marks or business names would not be permitted under the TGA requirements.

Actions you should take now

  • Medicinal cannabis businesses should ensure compliance with the marketing restrictions imposed by the TG Act and Code, and as outlined by the TGA Guidelines, and consider how compliance will impact overall branding strategy.
  • Consider potential business names, branding and the choice of trade marks at an early stage to avoid spending resources or registrations that you may not be able to use.
  • Investors should consider whether any cannabis business in which they propose to invest is compliant with these TGA marketing restrictions.