The regulatory landscape surrounding medical cannabis in Australia has undergone significant changes in recent years. After years of public debate and growing evidence of the potential medical benefits of cannabis, the Australian government legalized the use of medical cannabis in 2016. This move brought about a new era of research, development, and innovation in the country's cannabis industry.
The regulatory framework surrounding medical cannabis in Australia is overseen by the Therapeutic Goods Administration (TGA), which is responsible for assessing and approving medical cannabis products for use in Australia. The TGA is also responsible for ensuring that medical cannabis products meet the necessary safety and quality standards.
To access medical cannabis in Australia, patients must first obtain a prescription from an authorised medical practitioner. Medical practitioners must be registered with the TGA's Special Access Scheme (SAS) or the Authorised Prescriber Scheme (APS) to be able to prescribe medical cannabis. The SAS allows medical practitioners to apply for access to unapproved therapeutic goods for individual patients with a serious condition, while the APS allows authorized prescribers to prescribe medical cannabis to a group of patients with the same condition.
In addition to the SAS and APS, the TGA also operates the Provisional Access Scheme (PAS), which provides patients with access to new medical cannabis products that have not yet been fully approved. Under the PAS, patients can access new medical cannabis products that have been approved for use in other countries, subject to certain conditions.
The cultivation, production, and supply of medical cannabis in Australia is regulated by the Office of Drug Control (ODC), which is responsible for overseeing the licensing of cannabis cultivation and manufacturing facilities. To obtain a license from the ODC, cultivators and manufacturers must meet strict security and quality standards, as well as comply with Good Manufacturing Practice (GMP) guidelines.
The Australian government has also established a national regulatory body, the Australian Cannabis Agency (ACA), which is responsible for overseeing the import and export of medical cannabis products. The ACA is also responsible for monitoring and enforcing compliance with the various regulations and guidelines surrounding medical cannabis in Australia.
While the regulatory landscape surrounding medical cannabis in Australia is still evolving, there have been some notable developments in recent years. In 2020, the TGA announced a change in the scheduling of CBD, which is now available over-the-counter in pharmacies without a prescription, provided it contains less than 2% THC. This move has made it easier for patients to access CBD products for medicinal purposes.
Another notable development is the recent legalisation of the cultivation and manufacturing of medicinal cannabis in Victoria. In December 2020, the Victorian government announced that it would be legalising the cultivation and manufacturing of medicinal cannabis, making it the first state in Australia to do so. The move is expected to create new jobs and economic opportunities in the state, as well as provide patients with greater access to high-quality, locally-produced medicinal cannabis products.
Despite these developments, there are still some challenges facing the medical cannabis industry in Australia. One of the main challenges is the high cost of medical cannabis products, which can make it difficult for some patients to access the treatment they need. In addition, there is still some stigma surrounding the use of medical cannabis, which can make it difficult for patients to obtain prescriptions from their doctors.
Overall, however, the regulatory landscape surrounding medical cannabis in Australia is becoming more supportive of the industry. As research continues to demonstrate the potential medical benefits of cannabis, and as more patients and medical practitioners become educated about its use, it is likely that we will see further progress in the years to come.
Therapeutic Goods Administration. (2021). Accessing medicinal cannabis products: Information for consumers. Retrieved from https://www.tga.gov.au/accessing-medicinal-cannabis-products-information-consumers.
Office of Drug Control.