TGA guidance on the promotion of stem cells and HCT products

In brief 5 min read

The Therapeutic Goods Administration has issued advertising guidance for businesses involved with stems cells and other human cell or tissue products. As the guidelines explain, advertising restrictions may impact the use of trade marks, branding and company or business names. Providers of stem cells and other HCT products should pay close attention to the guidance, to avoid the material risk of civil and criminal penalties arising from non-compliance.

Key takeaways

• The Therapeutic Goods Administration (the TGA) advertising restrictions means that businesses must not refer to human cell or tissue (HCT) products 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 HCT products.
• Business names and branding, including registration of trade marks, should be considered at an early stage, to avoid spending resources that might not be able to be used. 

Who does this affect?

This affects providers of stems cells and other HCT products that are regulated as biologicals. This includes sponsors, manufacturers, importers, pharmacists, health professionals and marketers. Patient support groups also need to take care they do not promote, or encourage their members to seek out, HCT products when providing material to their members. 

What is an HCT product?

HCT products comprise, contain or are derived from human cells or tissues. The TGA is concerned that terms such as 'stem cells' are being used generically to advertise HCT products generally. Stem cells are a type of HCT product that are regulated as biologicals, as are most HCT products. 

Advertising restrictions

The advertising guidance the TGA (the TGA Guidelines) recently released has been made in accordance with the Therapeutic Goods Act 1989 (the TG Act) and the Therapeutic Goods Advertising Code (No 2) 2018 (the Code).

The TGA Guidelines remind stakeholders that the decision to use HCT products should be made in conjunction with a treating health professional. Advertising biologicals, including stem cells and other HCT products that are regulated as biologicals, to the public is prohibited under the TG Act. The TGA may apply civil and criminal penalties 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, or 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 would therefore be prohibited in relation to stem cells and other HCT products. These include:

• any statement, pictorial, representation or design that promotes the use or supply of stem cells and other HCT products;
• promotion of any health service involving HCT products that refers to HCT products, either overtly or by implication; and
• referencing additional information, such as links to websites and testimonials, that is promotional or endorses HCT products.

The TGA's concept of advertising applies to traditional forms of media such as television, radio, print media and posters/displays, as well as electronic media such as websites, emails, blogs, discussion forums and social media. Even material presented to the public in workshops or education sessions may be defined as advertising – it will turn on the content of the material and the context in which it is presented.

The ultimate question is whether the reference promotes the use or supply of HCT products from the end viewer's point of view, regardless of the advertiser's intention.

Navigating TGA requirements and using HCT-related trade marks

While it is possible to promote health services involving stem cells and other HCT products, such promotion must avoid any express or implied reference to HCT products. Businesses may not refer to HCT products 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 HCT products.

Similarly, colloquial names, abbreviations or acronyms must not refer to HCT products. Eg the TGA considers that a clinic named 'Far East Stem Cell 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 HCT products as part of its treatment service.

These restrictions mean it is likely that any trade mark or business name that references stem cell and other HCT products cannot be used by a business in promoting its health services, notwithstanding there is no restriction on the registrability of such trade marks or business names.

Accordingly, businesses with treatment services that involve stem cells and other HCT products should carefully choose what business or trading name and branding – including any trade marks – they adopt 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.

Anticipating the TGA's future approach to regulation and compliance

The TGA has adopted a consistent regulatory approach in relation to the promotion of HCT products and to businesses that provide treatment services involving medicinal cannabis. Those businesses must avoid any express or implied reference to medicinal cannabis, including in their company, business or trading names, in promoting their services (see our TGA guidance on the promotion of medicinal cannabis).

Other treatment services are beginning to emerge that, similarly to cannabis and stem cell therapies, are centred around the use or supply of a particular therapeutic good that encompasses a broader class of goods or products. Consequently, businesses that are intending to provide such services should anticipate the TGA's future approach to regulation, including potential restrictions around referencing other types of therapeutic goods in business names, trade names or products. Businesses should factor this in at the outset when deciding which business names and brands to use and trade marks to register.

Actions you can take now

Businesses involved in stem cells and other HCT products should:

• ensure compliance with the marketing restrictions the TG Act and Code impose, and the TGA Guidelines outline, and consider how compliance will impact overall branding strategy; and
• consider potential business names, branding and the choice of trade marks at an early stage, to avoid spending resources on registrations and branding strategies they may not be able to use.