Grow medical marijuana in Australia

Summary of Marijuana Laws

Since February 2016, the use of medical cannabis has been federally legal in Australia. The Australian Government has sole responsibility for regulating the cultivation and production of marijuana for medicinal and related scientific purposes. The manufacturing of, and patient access to, medicinal cannabis products is however a joint responsibility of the Australian Government and the states and territories. The Office of Drug Control (ODC) is responsible for regulating medical marijuana laws and issuing medical marijuana licenses and permits.

With its market dynamics similar to Canada just a few years ago, Australia is emerging as another top choice among speculative investors. According to the Parliamentary Budget Office, legalizing cannabis would reap the Australian economy almost $2 billion a year. Australia’s Green Party is actively pushing for the legalization of recreational cannabis.

The ODC has issued three types of licenses: cultivation or production of medical cannabis, research, and manufacturing of a drug or product. As of July 2018, the ODC has granted 18 medical cannabis cultivation licenses, 10 research licenses, and 13 manufacturing licenses since the process began in February 2017. There is no limit to the number of medicinal cannabis licences that can exist.

Content updated: August 1, 2018.

Key Dates

Application Fees/Start-Up Costs

Available License Types

Qualifying Conditions

History

On Wednesday, February 24, 2016, the Australian Parliament passed a measure legalizing the cultivation of medical cannabis. While prescribing and manufacturing medicinal cannabis products in Australia has been legal under strict circumstances in the Therapeutic Goods Act, the new legislation for the first time legalized the growing of medical cannabis.

“The Narcotic Drugs Amendment Bill 2016 will establish a robust and secure system for the cultivation of cannabis for medicinal and related scientific purposes, consistent with Australia’s international obligations. This cultivation is the missing piece of the puzzle that will facilitate the development of products, promote scientific research into the potential uses of cannabis and raise awareness among the medical profession and patient groups about the options for treatment. Importantly, it puts the medical professional back into the decision making process to ensure better outcomes for patients, while ensuring that patients have a safe supply of product.”
[Narcotic Drugs Amendment Bill 2016: Public Information paper. 10 February 2016. ]

The amendment resolves the “missing piece” of prior legislation – domestic medical cannabis cultivation. Doctors with “Authorised Prescriber” status were already certified to prescribe medical cannabis, which was intended to be imported through legal channels. Patients would qualify under the “Special Access Scheme.”

The new amendment does not change this procedure for patient access under the Therapeutic Goods Act 1989, only authorizing domestic cultivation in place of international supply, which was limited and problematic.

International commitment to the Single Convention on Narcotic Drugs leads to caps on cannabis production

Australia’s primary obligation under the Single Convention is to prevent the diversion of cannabis to illicit uses. The State is also obligated to take sole legislative responsibility for licensing and determining where cultivation can take place. While State and Territories will have input through their scheduling process (below), the State will be the sole regulator.

Australia intends to tightly control the amount of cannabis produced, striving to allow only enough cannabis to meet current demand. Permits will be managed relative to proposed usage. This will prevent any accumulation of cannabis or cannabis products.
• The Secretary of the Department of Health will have the power to order the destruction of any cannabis produced by a license holder. This will contribute to preventing any ‘unnecessary accumulation.’

Australia’s Department of Health will also report regularly to the International Narcotics Control Board at the United Nations.

Proposed rescheduling of cannabis eases patient access

Consumer and patient access to medicines and chemicals in Australia is dependent on the schedule of the substance. Cannabis is currently a prohibited substance under Schedule 9 at the federal level Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), meaning manufacture, possession, sale, or use of cannabis is prohibited unless approved by relevant authorities for medical or scientific research. As detailed by the Therapeutic Goods Administration (TGA), “Down scheduling of medicinal cannabis products from Schedule 9 (S9) Prohibited Substances to Schedule 8 (S8) Controlled Drug in certain circumstances came into effect on 1 November 2016. It is a matter for the states and territories to implement this scheduling decision into the relevant law in their jurisdictions to reduce the number of restrictions placed on their manufacture, supply, possession and use, to facilitate access to appropriate patients.”

At the federal level, there is a proposal to reschedule cannabis, cannabis extracts, and THC that is botanically derived from cannabis, for therapeutic use when produced, manufactured or imported through legal means. This would shift medicinal cannabis products to Schedule 8, aligning with the scheduling of morphine and other restricted medicines. Cannabis and THC would remain Schedule 9 when it does not fit the above criteria or when not for human therapeutic use.

Each State and Territory is responsible for enacting medicines scheduling legislation, and SUSMP decisions are only operationalized or made legal when adopted into state or territory legislation. These local jurisdictions may vary in how the scheduling is applied.

Each product must benefit a defined patient group

Although Authorized Prescribers could already prescribe medical cannabis products for their patients, acquiring those products (especially with specific desirable characteristics for particular circumstances) is difficult with the reliance on supplies from international sources. This amendment reflects a growing community expectation that patients should have ready access to appropriate medical cannabis products.

Patient access will be dictated by product type. Products will either be part of a clinical trial with a defined patient description or identified after trials as appropriate for a defined patient group. Authorized Prescribers will be able to prescribe specific products for patients who fit the defined patient groups.

For now, only Australian patients will have access to medical cannabis through this program. However, Australia may consider exporting cannabis in the future after the new system has had time to demonstrate to the international community that it is robust and secure.

Treating cannabis consistently with other narcotic drugs

Australia is endeavoring to treat cannabis the same way it treats any other narcotic drug. The amendment Bill modified the Narcotic Drugs Act 1967, in particular requiring that any license for manufacturing narcotic drugs (such as morphine) has the same “fit and proper” requirement as that for cannabis cultivation. The applicant/license holder and all relevant business associates must be “fit and proper.”

This means that all manufacturing licenses that are transforming raw cannabis into a finished product will need to meet the same higher standard, reducing the potential to shift criminal activity to another stage in the supply chain.

Similarly, all medicinal cannabis products will be subject to the quality manufacturing requirements under the Therapeutic Goods Act 1989 – the same high safety standards that are applied to any other medicine.