IN BRIEF - PATIENTS MUST FIRST OBTAIN FEDERAL AND STATE APPROVALS
In February 2016, amendments to the Narcotic Drugs Act 1967 (Cth) (ND Act) and the Therapeutic Goods Act 1989 (Cth) (TG Act) provided for a new legislative framework for accessing medicinal cannabis in Australia. The complexity of the framework, however, means that it can be difficult to navigate. We take a look at the new framework as it applies to patients and medical practitioners seeking access to medicinal cannabis.
This is the second article in our two part series on the regulatory framework surrounding medicinal cannabis in Australia. Our first article can be accessed here: Medicinal cannabis - cultivation, production, and manufacture.
MEDICINAL CANNABIS INDUSTRY KEY TERMS
- Cannabis: (marijuana) the plant of the genus Cannabis.
- Medicinal Cannabis: cannabis products prescribed to relieve the symptoms of a medical condition.
- Cannabinoids: the components contained within the cannabis plant that produce pharmacological effects.
- Cannabidiol: (CBD) a non-psychoactive cannabinoid that has appears to have positive effects on patients.
- Tetrahydrocannabinol: (THC) the principal psychoactive cannabinoid of cannabis.
- Industrial Cannabis: (Hemp) cannabis with a THC level of no more than 1%, primarily used for its fibre and oil.
- Cultivation: growing the cannabis plant.
- Production: harvesting the cannabis plant.
- Manufacture: the extracting of active ingredients from the cannabis plant, and creating medicine in its dosage form.
The key cannabinoids used in medicinal cannabis are THC and CBD. They have shown positive effects on patients suffering from a wide range of illnesses.
NARCOTIC DRUGS ACT ENABLES AUSTRALIA TO MEET ITS UN NARCOTICS CONVENTION OBLIGATIONS
Australia is a signatory to the United Nations' Single Convention on Narcotic Drugs (1961) (Convention), an international treaty to prohibit production and supply of narcotic drugs except for specific purposes such as medical treatment and research.
The ND Act enables Australia to meet its obligations under the Convention, particularly to ensure that domestic supply of narcotic drugs do not exceed domestic medicinal and scientific demand.
COMMONWEALTH AND STATES JOINTLY RESPONSIBLE FOR ACCESS AND DISTRIBUTION
The TG Act is a federal law administered by the Therapeutic Goods Administration (TGA), part of the Commonwealth Department of Health. The ND Act is also a federal law and is administered by the Office of Drugs Control (ODC), a new body established under the new framework within the Commonwealth Department of Health.
Access to and distribution of medicinal cannabis products is a joint responsibility between the Federal Government (through the TGA and the ODC) and the states. Patients must obtain both the relevant federal and state approvals.
MOST MEDICINAL CANNABIS DRUGS ARE UNREGISTERD GOODS THEREFORE NOT SUBSIDISED BY FEDERAL GOVERNMENT
The TGA is responsible for the Poisons Standard in which, until recently, cannabis and its related compounds were listed within Schedule 9 - Prohibited Substances. On November 1 2016, in line with the new legislation, cannabis was relisted under Schedule 8 - Controlled Substances. CBD was listed as a separate substance to cannabis for the first time, and placed in Schedule 4 - Uncontrolled but Prescribed Drugs.
Products which contain substances in Schedule 4 or 8 of the Poisons Standard must be registered on the TGA's Australian Register of Therapeutic Goods (ARTG) to be considered a "registered good". Registered goods are assessed for safety, quality and efficacy. Goods that are not registered on the ARTG cannot be subsidised by the Federal Government.
The ARTG listing process is onerous, costly, and slow to comply with. Further, medicinal cannabis derived from natural cannabis (rather than synthetic) consists of a series of complex compounds which operate together when administered to patients. For this reason, neither this series of compounds nor the entire plant can be registered on the ARTG. So most medicinal cannabis drugs, as unregistered goods, are not subsidised by the Federal Government, and patients must pay full market price for the drugs.
PATHWAYS TO ACCESSING UNREGISTERED DRUGS
Unregistered goods, including medicinal cannabis, are not assessed for efficacy by the TGA and, unless they are forbidden by state or territory law, are supplied through:
- the Special Access Scheme
- the Authorised Prescribers Scheme, or
- clinical trials
Special Access Scheme (SAS)
The SAS provides a pathway for the import or supply of medicinal cannabis for a single patient, on a case-by-case basis. Patients are grouped into two categories under the scheme:
- Category A: terminally ill patients, or
- Category B: all other
Category A patients currently cannot gain federal approval for access to medicinal cannabis through the SAS.
Authorised Prescribers Scheme (APS)
A medical practitioner may be granted authority by the TGA to become an "Authorised Prescriber" of medicinal cannabis to specific patients with a particular medical condition.
To be an authorised prescriber, the medical practitioner must:
- have the training and expertise appropriate for the condition being treated and the proposed use of the product
- be able to best determine the needs of the patient
- be able to monitor the outcome of therapy
Once a medical practitioner becomes an authorised prescriber they do not need to notify the TGA when they are prescribing the medicinal cannabis. However, they must report to the TGA the number of patients treated on a six monthly basis.
Federal approval can also be gained through clinical trials. A trial must have an Australian sponsor which may be an individual, a body or organisation, or a company. The TGA deals directly with the sponsor on all matters relating to the trial.
HOW PATIENTS CAN OBTAIN STATE APPROVALS - THE QUEENSLAND EXAMPLE
As different states have different legislation, a patient's access to medicinal cannabis will depend on where they live. This article focuses on the Queensland legislation.
Until recently, under the Health (Drugs and Poisons) Regulation 1996 (Qld), cannabis was a prohibited substance in Queensland.
On 1 March 2017, changes to the Public Health (Medicinal Cannabis) Act 2016 (Qld) (PHMC Act) commenced, creating a new regulatory framework to allow medicinal cannabis to be prescribed and dispensed to patients in Queensland while also preventing unauthorised use of these products. The new PHMC Act defines medicinal cannabis as a good not listed on the ARTG. Any cannabis used outside of the regulatory framework will be illegal.
There are now two pathways for a patient in Queensland to receive state approval for treatment with medicinal cannabis:
- Patient-Class Prescriber
- Single-Patient Prescriber
Under the patient-class prescriber pathway, a certain class of specialist doctors may be granted an as-of-right authority to prescribe specific medicinal cannabis products for patients suffering a specific range of conditions, without the need for any additional chief executive approval. The patient classes which can currently access this pathway include multiple sclerosis induced spasticity, drug-resistant epilepsy, chemotherapy induced nausea, and terminally ill patients.
To become a patient-class prescriber, a doctor must be within the class of specialists listed in the regulation. They must also inform Queensland Health each time that they prescribe, supply, or administer medicinal cannabis.
The single-patient prescriber pathway allows a medical practitioner, who believes their patient may benefit from treatment with medicinal cannabis, to apply to Queensland Health for approval to prescribe a medicinal cannabis product for the patient.
In contrast to the patient-class prescriber scheme, under the single-patient prescriber pathway, medicinal cannabis approvals, dispensing approvals or clinical trial approvals all involve case-by-case application, consideration, approval and review processes.
APPROVED PHARMACISTS MAY DISPENSE MEDICINAL CANNABIS
To support both the single-patient prescriber and patient-class prescriber frameworks, the ODC grants dispensing approvals to approved pharmacists to dispense medicinal cannabis under strict conditions.
In February 2017, the Federal Government announced changes to Schedule 5A of the Therapeutic Goods Regulations 1990 to allow companies to apply for approval to import medicinal cannabis products into Australia for sale to patients with the necessary federal and state approvals. This amendment is explained further in our February 2017 article Medicinal cannabis access made easier for approved patients.
KEY ISSUES FOR MEDICINAL CANNABIS PATIENTS AND PRESCRIBERS
The recent legislative changes do make it possible to access medicinal cannabis in Australia. However, the system is not without faults. These are largely generated by the incompatibility of medicinal cannabis with the current narcotics legislative framework, particularly in regard to the following characteristics:
- the process is slow, costly, and difficult, particularly for patients requiring urgent access to medicinal cannabis
- the drugs are also not available to terminally ill patients, who arguably are most in need
- the requirement for both state and federal approval adds unnecessary complexity to the accessing process
- most medicinal cannabis drugs are not subject to government subsidies
Colin Biggers & Paisley
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.