16 June 2017

What is the effect of the disallowance motion?

The disallowance of items 1 and 4 of the Therapeutic Goods and Other Legislation (Narcotic Drugs) Regulation 2016 means that imported medicinal cannabis products only, not domestically produced product, can now be supplied through the Special Access Scheme Category A, albeit by patient-by-patient imports (see Medicinal Cannabis Products: Special Access Scheme Category A).

The disallowance does not affect the operation of the Narcotic Drugs Act 1967 (the ND Act).

Additionally, product imported under the interim sponsored import policy announced in February is unable to be used under the Special Access Scheme Category A. This product is limited to use under the Special Access Scheme Category B, the Authorised Prescriber Scheme and clinical trials.

Disallowance motion does not allow domestic suppliers to use Special Access Scheme Category A

The Senate vote of 13 June 2017 does not affect the supply pathways available to manufacturers of medicinal cannabis products licensed under the ND Act.

The ND Act contains specific provisions setting out the supply options. These options do not include the Special Access Scheme Category A. The disallowance of items 1 and 4 of the Therapeutic Goods and Other Legislation (Narcotic Drugs) Regulation 2016 undoes the government's intended effort of ensuring that imported product is treated in the same way as domestic product.

What does the Narcotic Drugs Act say?

Section 11K of the ND Act says that the Office of Drug Control cannot grant a manufacture licence unless satisfied that the medicinal cannabis product will only be supplied through certain pathways.

These are clinical trials (11K(2)(b)(i)); an 'approval' or an 'authority' granted under the Therapeutic Goods Act 1989 (11K(2)(b)(ii)); as prescribed in regulations (11K(2)(b)(iii)); or as registered product (11K(2)(c)).

The Special Access Scheme Category B is an 'approval' under the Therapeutic Goods Act (see section 19(1)).

The Authorised Prescriber Scheme is an 'authority' (see section 19(5)).

The Special Access Scheme Category A is an 'exemption' (section 18) under the Therapeutic Goods Act and therefore is not covered by the provisions set out under 11K.

The Office of Drug Control cannot grant a licence that would allow domestically manufactured product to be supplied through the Special Access Scheme Category A. It would be a breach of the conditions of a manufacture licence for a manufacturer to supply through that route.

What about terminally ill patients?

Terminally ill patients can still be prescribed medicinal cannabis products. Doctors can apply through the Special Access Scheme Category B and a doctor that is familiar with the product can receive approval in as little as two days.

Alternatively, a doctor can apply to be an Authorised Prescriber. A doctor who is an Authorised Prescriber can prescribe without any delays.

Doctors working in hospitals might also be able to acquire domestic medicinal cannabis products for supply to a terminally ill patient another way. When the Government made the Narcotic Drugs Regulation 2016, it made a provision that allows a pharmacist working in a public hospital to manufacture a medicinal cannabis product for supply to patients in that hospital or in other public hospitals in that state.

For this type of hospital-produced product, the doctor does not require approval or authority from the TGA in order to prescribe (but must comply with relevant state/territory legislation).

How does this work with the local industry?

A manufacturer licensed under the ND Act is able to supply a public hospital with extracted cannabis material.

The pharmacist in that public hospital can use that material to compound a final product.

That final product can then be supplied to any public hospital in that state for prescription by a doctor to a patient, either on an in-patient or out-patient basis.

The below table summarises how product can be accessed under the various pathways.

Product Special Access Scheme Category A Special Access Scheme Category B Authorised Prescriber Compounded in public hospital
Imported - patient by patient yes yes yes yes
Imported - under sponsored import policy yes yes yes yes
Domestically cultivated and manufactured yes yes yes yes

For more information, please visit the import and export page.