Consumer group Your Health Your Choice has launched a Facebook campaign urging the public to write to their MP in a bid to stop the Therapeutic Goods Administration’s ‘limited’ plan to make CBD a schedule 3, pharmacist-only medicine.
The move comes after the industry raised concerns that the TGA’s plan was a “red herring” which would not increase patient access to medicinal cannabis.
While the TGA concluded low-dose CBD – defined as a maximum daily dose of 60mg – had an “acceptable safety and tolerability profile”, under tight regulations all schedule 3 medicines must be registered on the Australian Register of Therapeutic Goods (ARTG) and proven to work – very difficult at such low doses.
Your Health Your Choice is aiming to get 10,000 people to write to their MP before the TGA announces its interim decision, expected on September 9. The group is working in collaboration with the Australian Medicinal Cannabis Association (AMCA) to raise awareness about CBD down-scheduling.
While the ‘CBD Act Now’ campaign does not dictate what consumers say in their correspondence, it sets out three down-scheduling options:
- “Pharmacist only (schedule 3). This is where you must speak to a pharmacist before you buy it from them. However, companies cannot receive marketing approval to sell as a registered product in pharmacies unless they can first prove to the TGA that they have clinical trials ‘proving’ that it works, making it very difficult and more expensive to sell. At the very low dose proposed, it is possible that a product would not become ‘proven’ and therefore approved for years. Special access or exemption schemes may allow limited supply however CBD products in the main would remain difficult and expensive to obtain.”
- “Pharmacy only (schedule 2). You can only buy CBD from a pharmacy (without needing to talk to a pharmacist), but all else is the same as above.”
- “Unscheduled. This is how most vitamins, minerals, herbal tablets, and many throat lozenges, sunscreens etc are sold in Australia, or even the painkillers and cough syrups that you are allowed to buy in supermarkets. The TGA does not allow high-risk claims, as they do not approve the evidence before the products are allowed to be sold. As long as the company follows TGA requirements for the supply of these types of products, including requirements relating to manufacturing quality and advertising, any company can sell unscheduled medicines, including in retail shops and online stores. This means that many high-quality products can become readily available, making it cheaper and easier for people to access.”
An online form allows the public to identify – and send a personalised message direct to – their local federal member or state senator while a video explains the issues at stake.
The group previously used its campaigning muscle to drive public submissions to the TGA during its consultation period, resulting in 5,399 responses. It claims more than 95% favoured wider access to CBD while fewer than 5% supported the TGA’s preferred option.