Updates to Medicinal Cannabis Legislation

The term ‘medicinal cannabis’ can be used to describe a range of preparations derived from cannabis that are intended for therapeutic use. Medicinal cannabis may include refined pharmaceutical products containing natural or synthetic cannabinoids or standardised products containing herbal cannabis or plant products. These products are considered therapeutic goods in Australia. Therefore, unless there is an exemption, they must be approved and included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied.

Nabiximols (Sativex^®) is the only cannabinoid currently listed on the ARTG. It is approved for the symptomatic management of patients with moderate to severe spasticity due to multiple sclerosis. However, nabiximols is not currently marketed in Australia, making access difficult for patients. Other medicinal cannabis products that are not included on the ARTG may still be accessed. This may occur through the Special Access Scheme (SAS), Authorised Prescriber (AP) pathway, or as part of a clinical trial.

The SAS allows for the importation and supply of unapproved therapeutic goods for a single patient. This supply pathway can be divided into Category A and Category B. Category A applies to patients who are ‘seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.’ Category B, which applies to all other patients not covered by Category A, is the arrangement used for medicinal cannabis.

The other supply pathway, the AP Scheme, grants authority to a medical practitioner to prescribe an unapproved therapeutic good, or class of therapeutic goods, to specific patients with a particular medical condition. Once a prescriber is a certified AP, they can supply those products to individual patients in their immediate care without any further approval by the Therapeutic Goods Administration (TGA). An AP is required to report the number of patients treated with the unapproved product to the TGA on a biannual basis.

To be eligible for AP status, a medical practitioner must meet the following conditions:

• Possess expertise and have completed training appropriate for the condition being treated and the proposed use of the unapproved product.
• Ability to determine the needs of the patient.
• Ability to monitor the outcome of therapy.

These two pathways are an important step in the safe evolution of the ARTG. It allows patients in great clinical need to access treatments they would not otherwise be able to, while also allowing the TGA time to gather and analyse emerging clinical trial data to support the future registration of that product. However, importing products for specific patients is cumbersome for prescribers and may be frustrating for patients. The inherent inefficiencies of these pathways add considerable time to the delivery of therapeutic goods and may also add considerable costs to the consumer.

Key pieces of legislation have already been amended to support a more efficient supply process. On 30^th October 2016, legislation came into effect to allow the legal cultivation, production, and manufacture of medicinal cannabis products in Australia. This scheme is managed by the Office of Drug Control (ODC) and is designed to improve the supply of medicinal cannabis products for certain patients. On 17^th February 2017, the ODC issued its first licence under the medicinal cannabis provision of the Narcotic Drugs Act 1967. This landmark decision complements the changes to importation legislation later announced by the Department of Health on 22^nd February 2017.

The February changes now allow importers to source medicinal cannabis products internationally and warehouse them securely in Australia. It is anticipated that this will solve the immediate supply issues while domestic production and manufacturing schemes are established. The Department of Health has already contacted a number of companies in relation to these arrangements, and it is expected that a store of imported medicinal cannabis products will be available in Australia within the next eight weeks.

While the importation arrangements for medicinal cannabis products have been relaxed, the restrictions placed on supply have not. Medicinal cannabis is still highly regulated and subject to additional state and territory laws which further complicates supply. It is currently legal for varying indications in Victoria, the Australian Capital Territory, New South Wales, Western Australia, and Queensland. Legislative frameworks are currently under review in South Australia and Tasmania, while the Northern Territory is yet to announce their position.

Victoria was the first state to endorse medicinal cannabis and remains on target to deliver locally produced medicinal cannabis products to children with severe epilepsy in the coming months. However, an urgent clinical need has been acknowledged for children with the most severe symptoms of intractable epilepsy. On 1^st March 2017, the Victorian Government announced the accelerated supply of cannabidiol oral solution to some of the most severely affected children. Twenty-nine children, carefully selected by a clinical panel, now have access to medicinal cannabis through this compassionate access arrangement. This product has been imported from Canada, taking advantage of the recent changes to import legislation. It is anticipated that other children with severe intractable epilepsy will have access to locally produced medicinal cannabis by the middle of 2017.

These recent legislation changes are promising signs for the many patients and advocacy groups who have long campaigned for improved access to medicinal cannabis in Australia. Once warehouse supplies are established in Australia, the timeliness of supply to the end-user will improve significantly. The costs of importation should also be considerably reduced. However, while medicinal cannabis is not subsidised on the Pharmaceutical Benefits Scheme (PBS), procurement costs may be prohibitive for some patients.