With the Narcotic Drugs Amendment Bill 2016, the Australian Commonwealth legalized medical marijuana in Australia in 2016. This legislation intended to meet three needs:
• Authorize medical cannabis cultivation domestically, for medicinal and related research purposes
• Satisfy the requirements of Australia’s international obligations, under the Single Convention on Narcotic Drugs
• Align medical cannabis access with that of other restricted medications
Applicants and business partners must be “fit and proper”
The idea of “fit and proper” is designed to exclude criminal elements, including organized crime, and prevent the license scheme from being a cover for illegal activities.
Cannabis is considered to have a high risk of diversion because its “raw” flower state is readily usable, and therefore attractive to organized crime. “Fit and proper” requirements are intended to prevent any applicant from receiving a license if the applicant or any relevant business associate has a tie to criminal activity.
Applicants must also have the financial resources to participate in the industry and must be able to satisfy security and other conditions of the license.
Prior cannabis conviction does not necessarily disqualify applicants
The Amendment Bill specifically includes an “exception in special circumstances” for individuals with prior cannabis-related offenses. Under this exception, applicants may not be disqualified solely because of an offense related to the cultivation, production, obtaining, or supply of cannabis, cannabis resin, or related products.
Applicants must disclose the circumstances in the application and must be able to comply with all requirements.
“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.