Cannabidiol

The Hon. T.A. FRANKS (15:11): I seek leave to make a brief explanation before addressing a question without notice to the Minister for Health and Wellbeing on the topic of consumer access to CBD, or cannabidiol.

Leave granted.

The Hon. T.A. FRANKS: CBD is a non-intoxicating component of the hemp plant. Evidence suggests it has beneficial effects in treating conditions such as epilepsy, anxiety, pain and insomnia while carrying few, if any, risks of major side effects or addictions.

In early September, the TGA announced that it may allow over-the-counter access to CBD products in Australian pharmacies from mid-2021. However, analysis from the Lambert Initiative, which is a not-for-profit research centre at the University of Sydney, has rung alarm bells. It shows that the maximum doses permitted under the TGA proposal—that is, 60 milligrams—are nowhere near high enough to provide therapeutic benefit to most patients. Indeed, they say the benefits begin somewhere between 300 and 1,500 milligrams per day.

The Lambert Initiative has also identified that Australia lags behind other countries on consumer access to CBD products. My question to the minister is: what will the minister do to ensure that the enabling of CBD to be provided at pharmacies is not a mirage in a desert but indeed is at an appropriate dosage for patients not to have to resort to the black market?

The Hon. S.G. WADE (Minister for Health and Wellbeing) (15:12): I thank the honourable member for her question. The Marshall Liberal government is committed to ensuring that South Australian consumers have access to a range of treatments and services to promote the best possible health outcomes, and in that regard we continue to explore strategies to improve access for patients who may benefit from medicinal cannabis. This includes our commitment to the ongoing development of the national framework, signposting to clinical resources and education for doctors, and our adoption in 2018 of the TGA's online application process.

The department continues to work with clinicians to develop the optimal approach to patient access. As the honourable member indicates in her question, there have been a number of recent developments at the national level. In March, the Senate's Community Affairs References Committee published a report on the findings of its inquiry into the current barriers to patient access to medicinal cannabis in Australia. The report makes 20 recommendations, including education for prescribers, regulation considerations and the potential for down-scheduling of cannabidiol, or CBD as it is commonly known, further to a TGA safety review.

In April, the TGA published a safety review of CBD which found that CBD presents a good safety and tolerability profile at the low dosage of under 60 milligrams a day. On 9 September, the TGA announced its interim decision to facilitate greater access to CBD by down-scheduling it from Schedule 4 to Schedule 3 of the Poisons Standard, subject to a number of criteria being satisfied.

The proposed down-scheduling to Schedule 3 applies only to oral products such as mixtures, sprays and tablets with a recommended daily dose of 60 milligrams or less for adults aged 18 years and over. Schedule 3 medicines are restricted for sale by registered health practitioners and are available over the counter in pharmacies with pharmacist advice. I want to stress that the decision is an interim decision and is subject to further consultation up to mid-October, after which the TGA will announce their decision.

I am a politician, not a clinician. I accept the honourable member's reports that there are clinicians who have different views. That's not surprising, and that is why we have consultation. I urge the honourable member to make anyone who has issues with the interim decision aware of the opportunity to provide input.

If the final decision is to down-schedule CBD to Schedule 3, products could potentially be available over the counter from 1 June 2021. As South Australia adopts the national scheduling of medicines in the Poisons Standard, this change to the scheduling of CBD—if it goes ahead—will apply in South Australia. CBD in higher dose preparations and for the treatment of children remains in Schedule 4 as a prescription-only medicine.