In Australia, almost all prescription medicines supplied to patients are ‘registered’. This means that the Therapeutic Goods Administration (TGA) has assessed them for safety, quality and effectiveness. Patients need to know that the medicines they are taking are safe and should help them.
Sometimes, however, registered medicines are not suitable for a particular medical condition. In these cases, doctors may seek approval to use an unregistered medicine. This is a medicine that has not been assessed for quality, safety or effectiveness by the TGA. All medicinal cannabis products, with the exception of Sativex, are unregistered.
The TGA has a number of schemes to allow doctors to supply unregistered medicines. These are: the Special Access Scheme Category A (SAS-A) and Category B (SAS-B); the Authorised Prescriber Scheme (AP); as well as through clinical trials.
SAS-B and AP applications require approval from the TGA before the unregistered medicine can be supplied to the patient. The Special Access Scheme is an approval for a single patient and is issued on a case by case basis. Authorised Prescribers can prescribe a specific unregistered medicine to specific patients with a specific condition (for example, children with refractory epilepsy).
SAS-A allows for the immediate use of unregistered medicines without TGA approval (as is required for products accessed through SAS-B and AP) in terminally ill patients where the patient might die without early treatment. Doctors send a notification form to the TGA after they have supplied the unregistered medicine which means that there is no regulatory oversight by TGA. The medicines accessed through SAB-A (and also through SAS-B and AP) have an established history of safe clinical use in other countries and the overwhelming majority are approved for general sale in comparable overseas countries. For these medicines, this provides a high degree of assurance that they can be safely supplied to the Australian public. This is not the case for most medicinal cannabis products.
Medicinal cannabis products supplied in Australia must also comply with the TGA’s quality standard for medicinal cannabis products before they are given to patients. This is assessed by the TGA as part of the assessment process for SAS-B and AP applications. Compliance with this quality standard cannot be assessed if supply occurs through SAS-A.
The States and Territories have a role in supply of unregistered medicines through their Drugs and Poisons legislation and doctors may require approval before they are able to prescribe a particular medicinal cannabis product in their State or Territory. This is separate to any requirements of the TGA.
Doctors have always had to seek approval to supply most unregistered medicinal cannabis products under the SAS-B and the AP Scheme. This is because cannabis and tetrahydrocannabinols were in Schedule 9 (Prohibited Substance) prior to their rescheduling in certain therapeutic circumstances in November 2016, and medicines in Schedule 9 cannot legally be accessed through SAS-A.
The TGA assesses the clinical justification for using any unregistered medicine and whether it complies with the quality standard, under the SAS-B and AP Scheme, to help ensure that the medicine can be appropriately supplied to patients. For a correctly completed application, TGA takes on average 2-3 working days to approve SAS-B applications for medicinal cannabis products. In addition, Authorised Prescribers must get endorsement from an Ethics Committee for their proposed treatment protocol.
When the Government announced the scheme in October 2015 to allow the cultivation of cannabis in Australia for medicinal purposes, it stated that prescription would be in accordance with the existing arrangements. This includes supply though SAS-B, AP, clinical trials or as a registered medicine. These requirements are set in the Narcotic Drugs Act 1967, which stipulates that a manufacture licence cannot be granted unless the Department of Health is satisfied that the product will be used in one of these four ways.
In summary, medicinal cannabis products are not yet ‘established pharmaceuticals’ and for this and all the reasons above it is in the interest of public health and safety that the government has adequate regulatory oversight around access.