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RHONDA MILES: Our 15 year old epileptic son Lachlan has been on life support seven times. He has been hospitalised 95 times in the last four and a half years… We welcome the Federal Health Minister’s moves last week in her announcement that she will set up a farm to pharmacy medical cannabis production system in Australia by 2018. That doesn’t help my son now. Why can’t we import through the special access scheme and TGA, quality-controlled medical cannabis oil from overseas now? FIONA NASH: … The special access scheme that exists, if there is a clinician that wishes to bring in a product that is not on the register of therapeutic goods, the capacity does exist to do that. – Minister for Rural Health, Fiona Nash, speaking on Q&A on October 26, 2015.

Minister Nash is correct.

It is possible to use the Therapeutic Goods Authority (TGA) to access unlicensed therapeutic goods such as cannabis-based medicines, which some people believe may help treat epilepsy. (The research on its efficacy is not conclusive). An unlicensed product may be imported usually through one of two ways - a clinical trial approved through an ethics committee, or through the Special Access Scheme (SAS).

When asked for a source to support her assertion, a spokesman for Nash sent a response from a TGA official that said the Special Access Scheme (SAS) can be used for the importation of a cannabinoid product for a person, but there may be state-based rules too. You can read the full response here.

The Special Access Scheme

The SAS is for compassionate use of unlicensed products for individual patients. There are two ways the scheme is applied:

Category A is for patients with terminally ill conditions, and it could reasonably be argued that certain types of severe epilepsy meet the criteria for a terminal illness.

A doctor can provide an unapproved product by securing supply from a manufacturer, and registering the application with the TGA. Formal assessment by the TGA is not needed.

However, Schedule 9 drugs, such as cannabis, cannot be supplied under Category A, although certain cannabis based products are no longer listed as Schedule 9 drugs, such as cannabidiol (CBD, Schedule 4), nabiximols (plant extracted THC/CBD, Schedule 8), or synthetic THC (e.g. dronabinol) – and these could be within scope for a Category A application.

The other SAS category, Category B, applies to all other patients, and there is no restriction to Schedule 9 drugs being used.

Category B applications undergo greater scrutiny by the TGA and are assessed on a case-by-case basis.

The TGA’s assessment balances a number of factors, including:

The patient’s doctor must be able to justify using the product, demonstrating the seriousness of the patient’s condition and the history of other treatments.

Information about the route of administration, dose, active ingredients, proposed monitoring procedures, and any data on the safety and efficacy of the product.

The prescriber must have the relevant expertise appropriate to the condition being treated.

Each case is assessed on an individual basis, and the process can take several weeks to months. A clinical trial model may be more appropriate for groups of patients with a particular condition seeking to use an unlicensed product.

Clinical trials

Unlicensed products can also be used under clinical trial conditions within the TGA framework using the Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes.

Clinical trials usually examine whether a medicine works (using a control group), but may focus more on safety (for example assessing side effects over an extended period of treatment). Safety studies are not uncommon as a means for enabling compassionate access to unlicensed medicines.

Investigational medicines must meet certain safety standards to be approved for clinical trials, and are assessed either by a human research ethics committee (CTN) or by the TGA (CTX). Cannabinoids (including plant matter) have previously been imported into Australia under these conditions, and there are several trials undertaking this process at present in Australia.

Whilst not commonly used, another mechanism for accessing unlicensed products through the TGA for compassionate use is the Approved Prescriber model, which requires many similar steps to establishing a clinical trial, with human research ethics committee approval.

Importing cannabinoid medicines

Both approaches require a high quality product that meets safety standards for use in humans. A range of existing cannabis based products meet these requirements, including pharmaceutical products (such as cannabidiol, dronabinol and nabiximols, although the latter two are THC-rich products unsuitable for pediatric epilepsy), and cannabis plant based products (including cannabis flower and cannabis extracted oils) manufactured under strict Good Manufacturing Practice standards. There are trials underway in Australia using such products.

Other potential products are the hemp-based oils such as Charlotte’s Web® from Colorado, or Endoca® from Denmark, although these CBD rich products are usually registered internationally as foods rather than medicines, and it is unclear as to whether these meet TGA standards.

Verdict

Minister Nash is correct. An appropriately qualified doctor could apply to the TGA to import or supply a cannabinoid product for a patient under the Special Access Scheme. However, cannabis plant matter or cannabis extracts (excepting cannabidiol-rich products) can only be considered under Category B of the SAS, and these products must meet production standards.

Alternatively, clinical trials could be established. – David Allsop and Nicholas Lintzeris.

Review

This is a sound analysis. The use of medical cannabinoids for epilepsy is a subject of much current interest, although the evidence for this is mostly anecdotal. This article describes the path to such treatment in Australia at the current time. Clearly, it would be a major undertaking for an individual patient. Most epileptologists would support the trial option where experience can be concentrated in expert hands for a clearly defined group such as people with Dravet syndrome. Only with quality evidence, properly collected, can the role of cannabinoids be established for general use in people with epilepsy. – Graeme Jackson.

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