Full response from TGA

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 an individual and this is not restricted to Sativex. A medical practitioner can apply through SAS Category B for a cannabinoid product and must provide information on the patient, clinical justification for treating the patient with an unapproved medicine and information on the cannabinoid product. This is always on a patient by patient basis.

Alternatively, the medical practitioner could apply under the Authorised Prescriber (AP) scheme where a medical practitioner can apply to prescribe an unapproved medicine for a class of patients for a particular indication/condition. If approved it is a more efficient route as the medical practitioner does not need to come back to the TGA for further patients with the same condition.

Note that in both SAS Category B and AP a delegate would need to assess the information provided with the application and a decision is made on a case by case basis dependent on the information provided.

A medical practitioner prescribing cannabinoid products that are in Schedule 9 (S9) of the Poisons Standard would also have a requirement to seek approval from the state/territory drugs and poisons regulators and the ability to give this approval depends on the state/territory the patient resides in.

As cannabis and cannabis derived products are Prohibited Imports under the Customs (Prohibited Imports) Regulations any importation would also require an import licence and permission to import for each importation. This requires a SAS or AP approval and state/territory approval where appropriate. As these products are Prohibited Imports any personal importation has these same requirements.

The Special Access Scheme (SAS) is an option for the supply of unapproved cannabinoid products (i.e. those not entered in the Australian Register of Therapeutic Goods (ARTG)) for a single patient on a case by case basis.

A SAS Category A notification can only be used for cannabinoids that are not in Schedule 9 (S9) of the Poisons Standard i.e. cannabidiol, nabiximols (e.g Sativex,) dronabinol and naboline. Where the cannabinoids in the product are in S9 then SAS Category A can not legally be used and an Australian registered medical practitioner would need to apply to the TGA for SAS Category B approval to treat the patient with the cannabinoid product.

Under Category B, the medical practitioner would need to provide clinical justification for treating the patient with an unapproved medicine over any alternative goods that are registered and available in Australia. Category B applications are assessed on a case by case basis to reflect the needs of different patients.

The major criteria for determining whether approval should be given relate to the patient, the product and the prescriber. The application should be received from a person with qualifications and/or expertise appropriate to the condition being treated and the proposed use of the product. Further information regarding the SAS is available at this website.

An alternative to SAS is the Authorised Prescriber (AP) scheme where a medical practitioner can apply to prescribe an unapproved medicine for a class of patients for a particular indication/condition. With the AP scheme the medical practitioner requires an ethics committee approval of the protocol to use the unapproved medicine and does not need to come back to the TGA for individual patients who fit the class of patients and the indication/condition. Further information is available here. The scheduling of the cannabinoid is not a constraint on whether an application can be made for AP.

Note that in both SAS Category B and AP, a delegate would need to assess the information provided with the application and a decision is made on a case by case basis dependent on the information provided.

Additional to the SAS or AP scheme there are other regulatory frameworks which may affect the ability to import a cannabinoid product.

Cannabis is currently listed as a Prohibited Substance under Schedule 9 (S9) of the Poisons Standard and this entry would capture all of its cannabinoid extracts that are not individually listed elsewhere in the Standard. Any manufacture, possession, supply or use of S9 substances would need state or territory approval, in addition to the requirements outlined above. The issuing of an approval for supply and use of S9 substance would be a state and territory responsibility and you would need to contact the drugs and poisons units in your state/territory for further information.

Cannabidiol, the cannabinoid used in clinical trials for the treatment of paediatric epilepsy syndromes, is in Schedule 4 (Prescription Only Medicine) of the Poisons Standard “in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis” and does not require state or territory approval. The SAS/AP approval and licence and permission to import outlined above would still be required to import such goods as cannabidiol. If permission was granted, the relevant permits would need to be presented to Australian Customs and Border Protection Service to import the medication into Australia.

Note that Nabiximols (active ingredients of Sativex) is in Schedule 8 (Controlled Drug - S8) of the Poisons Standard and also in Appendix D of the Poisons Standard. In view of this approval may be required by the state and territory before a medical practitioner can prescribe Nabiximols.

Cannabis and cannabis derived products are also Prohibited Imports under the Customs (Prohibited Imports) Regulations and as such require an import licence and permission to import for each importation. Once there is an approved SAS or AP the medical practitioner, or a pharmacy acting on behalf of the medical practitioner, would then need to apply for an import licence and permission to import from the Drug Control Section of the TGA, using the special access scheme import application forms available at this website.