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Responding to Lateline - accessing medicinal cannabis products

17 August 2017

This TGA behind-the-news article was published on 17 August 2017. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

The Lateline story on 16 August 2017 made claims that patients are turning to the black market for medicinal cannabis products because of excessive red tape, principally in seeking approvals under the Special Access Scheme Category B.

This scheme has operated for many years and the TGA provides over 20 000 approvals per year for doctors to prescribe a range of unregistered medicines. Clearly, it can and does work efficiently to meet the needs of patients.

Why are prescription levels for medicinal cannabis products relatively low? The Lateline story itself provided the answer. One of the interviewees, Justin Sinclair, stated, 'There is a great paucity of evidence in the literature, at least when it comes to human trials'.

Australia operates an evidence based system of medicine, which provides for the best possible care and, importantly, protection of patients. Mr Sinclair is correct and the very fact that there is a great paucity of evidence, including that of safety, means that it would be inappropriate to allow access without appropriate clinical oversight and would risk the health and safety of patients.

Doctors that have educated themselves on the available evidence and present their clinical justification can, and are, receiving rapid approvals (often within two working days) under SAS Cat B. Medicinal cannabis products are not treatments of first choice, precisely because they have not yet been assessed for safety, quality and efficacy. Until they are, it is appropriate to protect patient safety to ensure that doctors using these products are making an appropriate clinical decision based on sound evidence.

The TGA is working with states and territories to make it easier for doctors to assess the evidence on medicinal cannabis products, bringing together clinical guidances to assist in prescribing decisions. The first of these, on epilepsy and palliative care, will be available before the end of the year.

The TGA is also working with the states and territories to streamline necessary state based approval processes. The TGA is responsible for the supply of the product, while the states retain responsibility for approving doctors to handle schedule 8 substances. This is no different to any other schedule 8 medicine.

The TGA is very concerned about patients deciding to use black market products. Testing of these products has revealed in the past that they are not always as advertised and can contain dangerous levels of contaminants and other substances. Patients should always work with their doctor to determine the best possible, legal treatment regime.