TGA S3 announcement
Table of Contents
CBD Oil in low dose in Australia
CA Clinics response to the government announcement that CBD, incl CBD Oil, may be made available Over the Counter (OTC) as a Schedule 3 (S3) medicine.
Recently the TGA announced that they are starting a process of considering rescheduling of CBD to Schedule 3. If this rescheduling were to happen, products like CBD Oil in low dose, would be available over the counter (S3 / OTC) in Australia. The expected timeframe for low dose (S3 / OTC) CBD Oils and other product types to be available in Australia is 2021.
A summary of our response follows:
- We support the delegate-initiated proposal as outlined in the Public Notice of 24 April 2020 (item 2.5) to make low-dose CBD available (up to 60 mg per day), including cannabis CBD oil, as a Schedule 3 medicine
- Illicit CBD use is already widespread in the Australian community, with CBD Oil commonly sourced through the black market
- Illicit CBD Oils can be harmful and regulated products should be made available to subvert the illicit market
- Higher doses of CBD should continue to require medical support especially given they are often prescribed with THC medications and form part of broader treatment plan
- We believe the proposed amendments will:
- Further legitimise the use of medicinal cannabis, particularly CBD Oil as a treatment option
- Lower medication costs for many people
- Improve the speed of accessing low-dose (S3 / OTC) CBD oil and capsules
Use of medicinal cannabis as a treatment option
At CA Clinics we have treated thousands of patients using medicinal cannabis treatments, including CBD Oil which comprises up to 40% of our prescriptions, data as reflected in the Freshleaf Analytics report published in Q1. Many of our patients are prescribed these products under the CACOS study run through our own clinic network. We strongly believe that there are medical benefits for the use of medicinal cannabis, incl CBD Oil, as a treatment option. However, a tiered approach to access should be considered based on dosage and product types.
- Low dose CBD (<60mg per day)
- Higher dose CBD (>60mg per day)
- THC medications
Low dose CBD
Given the relatively low toxicity and general safety of CBD we consider that low dosage is appropriate for Schedule 3 categorisation and concur that a threshold of 60mg per day is appropriate.
Other medicinal cannabis products in Australia
Beyond the suggested definition of low dose CBD, we believe that other medicinal cannabis medications should continue to be accessed via doctor prescription as part of a treatment plan.
Our experience indicates that many patients prescribed medicinal cannabis, including CBD Oil, typically:
- Have complex case histories with co-morbidities
- Are receiving medication as part of a broader holistic treatment plan with interactions between a variety of medications and health care professionals
- Need managed titration of dosing to manage outcomes, costs, and side effects, especially at higher dosages
- Are prescribed a combination of CBD oil and THC products dependant on factors such as indications and work requirements
As such, these medications are best controlled via a doctor and any relevant approval processes. By limiting the daily dose, we expect that this would mitigate associated risks, with no real abuse potential for CBD.
Removing barriers to access CBD oil
The opportunity exists to streamline the process for people looking for CBD Oil or other CBD products as a treatment option, thereby reducing barriers to access and reducing economic costs.
For simple cases it broadens treatment options available for patients where they would not meet the category of “treatment of last resort”. Access to low-dose CBD Oil or other CBD products via pharmacies would reduce access bottlenecks where treating doctor and TGA support is currently required. Removing the necessity for a doctor consultation would further reduce patient costs and allow patients to proactively assess the efficacy of low-dose CBD Oil or other CBD products before considering if higher doses or other product types might be more suitable.
Introducing low-dose CBD Oil or other CBD products to the mainstream market will likely contribute towards greater acceptance of medicinal cannabis medications, potentially reducing the stigma about its broader medicinal use.
As these products become more mainstream, our key concerns relate to the quality and consistency of the product and the impact on consumer experience. This can be best managed through facilitating the ARTG registration of low-dose CBD Oil or other CBD products, which would have to meet quality and labelling standards. We note that, in the absence of such product registrations, patients may seek out illicit unregulated products, or compounded preparations. In addition, we would like to see measures in place to stop consumers circumventing the system by buying large quantities of low-dose CBD Oil or other CBD products to achieve higher dosages without visiting a doctor.
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