The Therapeutic Goods Administration (TGA) has issued a warning to prescribers of medicinal cannabis products over the use of the term ‘plant-based’ to describe their products. The TGA said that the term could be misleading and confusing for patients, as it implies that the products are natural or herbal, when in fact they are unapproved medicines that have not been evaluated for quality, safety or efficacy by the TGA.
Prescribers urged to end the ‘cat-and-mouse game’
The warning comes after a recent article published by Cannabiz, which featured an interview with Dr Ben Jansen, a leading prescriber of medicinal cannabis products in Australia. Dr Jansen said that he uses the term ‘plant-based’ to avoid the stigma and legal issues associated with the term ‘cannabis’. He also said that he believes that the TGA is ‘playing a cat-and-mouse game’ with prescribers, and that the TGA should focus on educating patients and doctors rather than enforcing regulations.
However, the TGA said that the use of the term ‘plant-based’ is not acceptable, as it does not reflect the true nature of the products, which are manufactured from cannabis extracts that contain various concentrations of cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD). The TGA also said that the term ‘plant-based’ could imply that the products are safer or more effective than other medicines, which is not supported by evidence.
The TGA reminded prescribers that they have a responsibility to provide accurate and clear information to their patients, and to obtain informed consent before prescribing unapproved medicinal cannabis products. The TGA also said that prescribers must adhere to the relevant standards of good medical practice, and report any adverse reactions or product quality issues to the TGA.
Access pathways and patient data for medicinal cannabis products
The TGA regulates the access to medicinal cannabis products in Australia, which are considered to be unapproved medicines. There are two main pathways for prescribers to access unapproved medicinal cannabis products for their patients: the Special Access Scheme (SAS) and the Authorised Prescriber Scheme.
The SAS allows prescribers to apply for access to unapproved medicinal cannabis products for individual patients who have a serious or life-threatening condition, and who have exhausted all other treatment options. The TGA evaluates each application on a case-by-case basis, and issues a decision within 48 hours of receiving all the required information.
The Authorised Prescriber Scheme allows prescribers who are specialists in their field to apply for authorisation to prescribe unapproved medicinal cannabis products to a group of patients with a specific condition, without the need for individual applications. The TGA assesses each application based on the evidence of safety and efficacy of the product, and the clinical expertise of the prescriber.
The TGA publishes data on the number of SAS and Authorised Prescriber applications and approvals for medicinal cannabis products on its website. According to the latest data, there were 12,397 SAS applications and 1,029 Authorised Prescriber applications for medicinal cannabis products in the first half of 2023. The majority of the applications were for products containing CBD, followed by products containing both CBD and THC.
Categories of medicinal cannabis products and product quality
The TGA has recently introduced a new system for submitting SAS and Authorised Prescriber applications for unapproved medicinal cannabis products, which is based on the active ingredient and the cannabinoid content of the product, rather than the brand name. The TGA has classified medicinal cannabis products into four categories:
- Category A: Products that contain only CBD, with a maximum concentration of 2% of other cannabinoids
- Category B: Products that contain both CBD and THC, with a CBD to THC ratio of at least 10:1, and a maximum concentration of 2% of other cannabinoids
- Category C: Products that contain both CBD and THC, with a CBD to THC ratio of less than 10:1, and a maximum concentration of 2% of other cannabinoids
- Category D: Products that contain other cannabinoids, such as cannabigerol (CBG) or cannabinol (CBN), or products that contain more than 2% of other cannabinoids
The TGA said that the new system aims to simplify the application process and reduce the administrative burden for prescribers and sponsors. The TGA also said that the new system will allow for better monitoring and reporting of the use and supply of medicinal cannabis products in Australia.
The TGA also regulates the product quality and manufacturing standards of medicinal cannabis products, and requires sponsors to comply with the Therapeutic Goods Order 93 (TGO 93), which specifies the minimum quality requirements for medicinal cannabis products. The TGA conducts testing of medicinal cannabis products being supplied via the SAS in Australia, and publishes the results on its website. The TGA said that the testing aims to ensure that the products are consistent with their labels and specifications, and do not contain any contaminants or impurities that could pose a risk to patients.
State and territory requirements for medicinal cannabis products
In addition to the TGA requirements, prescribers and pharmacists must also comply with the state and territory laws and regulations that apply to the prescription, dispensing, and supply of medicinal cannabis products. These laws and regulations may vary depending on the jurisdiction, and may include additional restrictions or conditions for accessing medicinal cannabis products.
The TGA provides information and links to the state and territory health departments on its website, and advises prescribers and pharmacists to contact their relevant health authority for further guidance and clarification. The TGA also encourages prescribers and pharmacists to consult with their professional bodies and associations for ethical and clinical advice on the use of medicinal cannabis products.