As many in the pharmaceutical industry know, the TGA has strict rules on advertising therapeutic goods. These rules are outlined via the Therapeutics Goods Advertising Code as well as guidance provided in Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
During the Australian Medicinal Cannabis Conference, the TGA were questioned on their approach to illegal advertising, and they encouraged the public to report suspected noncompliance. Their full response has been summarised in a previous blog.
Further to this, the TGA recently held a webinar that specifically covered Medicinal Cannabis Advertising Compliance and from this, we have summarised the main dos and don’ts for the industry when it comes to navigating this topic.
3 Key things you should know about compliant Medical Cannabis advertising
1. The regulator’s definition of “advertise”
The ARGATG defines “advertise” as the act of:
“making 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 label of the goods
- is on the package in which the goods are contained
- is on any material included with the package.”
This definition includes any content that fits this definition regardless of what media source or channel it is presented on.
2. You are NOT allowed to advertise directly to the public
The regulations specify that sponsors, retailers, and medical practitioners are not allowed to advertise the medicinal cannabis products directly to the public, this includes:
- Prescription medicines (Schedule 4 CBD and Schedule 8 THC)
- Restricted scheduled substances containing Schedule 3 medicines that are not exempt (so no Schedule 3 CBD advertising either)
- Illegal therapeutic goods (black market cannabis).
Alongside this, there are limitations on mentioning serious medical conditions without first applying for approval to do so from the TGA. (See section 30 of the Therapeutic Goods Advertising Code – it includes conditions like mental illness, HIV, neoplastic diseases, etc.)
3. You ARE allowed to advertise to health professionals
Health professionals are a wide category (and includes hospital purchasing officers); for more information go to the Australian Health Practitioner Regulation Agency. To facilitate this, it may be useful to design your website with pages and content that are only accessible by health professionals (e.g. they have to sign into a portal by inputting their AHPRA registration number).
How to write compliant Medicinal Cannabis content
Companies can generate content to advertise their business without promoting therapeutic goods, and it boils down to the intended consumer response, i.e. how will the consumer respond when viewing the content? Has the content been written in such a way that is intended to provoke a response or is it more factual and opinion-free?
The table below outlines some strategies to meet the TGA’s expectations:
If you responded yes to any of the above then you could be in trouble!
Content should be:
|Context||Has the content been placed in a context that now makes it promotional?
For example: a newspaper writes an article on a cannabis product and the manufacturer takes out an advertisement space on the opposing page that has no marketing spin but does contain the product’s information and specifications.
|ASX||ASX allowances are better covered in the Corporations Act 2001, but the following applies:
|Product details||If product details are mentioned, ensure that the details are as factual as possible, e.g.:
Avoid “this product has been listed in the ARTG BY the TGA.”
As explicitly stated in the TGA presentation you are not allowed to:
- have images or pictorial representations of cannabis plants or leaves
- have images or pictorial representations of
medicinal cannabis products
- include testimonials from consumers and case studies
- listing medical conditions suitable for therapy with medicinal cannabis.
If you want to read more on similar topics, the following blogs may also be of interest:
- The future of CBD
- New ODC guidelines align industrial hemp and medicinal cannabis industries
- S4 CBD for pets and livestock