To investigate variances of international approaches to the regulation of medical cannabis

Conclusions and Recommendations:

The primary conclusions from the Fellowship were that: more evidence is needed to describe the potential role of cannabis and cannabinoids as medicines; and, that Australia has developed a relatively robust and necessarily responsible approach to the regulation of medical cannabis products. Australia has ensured the cultivation and manufacturing framework is consistent with its obligations under the Single Convention and that access to these unregistered products has been occurring with a necessary level of regulatory oversight. This is directly related to Australia’s long and proven track record of effectively regulating the cultivation and manufacture of other narcotic plants (opium poppies) and our world-class medicines registration scheme, administered by the Therapeutic Goods Administration. 

Although access to cannabis for medical purposes has been an option for patients in other countries longer than in Australia, there was a consensus from regulators in all destinations that the global understanding of cannabis for medical purposes requires significantly more robust research to inform safe therapeutic outcomes and routine use in clinical practice. As a result of this, the recommendations of this Fellowship aim at addressing the gaps in knowledge about the potential role of cannabis in treating medical conditions and subsequently inform the current regulatory and policy landscape to enable safe and timely supply.

Recommendations from the Fellowship include the need for:

• Increased agronomic/botanical research to inform our fundamental scientific understanding of the cannabis plant and its constituents
• Increased research to inform the fundamental pharmacological, pharmacodynamic and pharmacokinetic properties of the different cannabinoids and their effect on the human body
• Significantly increased high-quality human clinical trial research to inform the development of profession-led, high-quality evidence-based clinical practice guidelines to ensure safe and effective use of medical cannabis products
• Ensuring routine regulatory data is collected and appropriately published where medical cannabis has been prescribed in Australia to contribute and enhance our understanding of its potential clinical applications
• Medicines regulators to remain open to emerging high-quality evidence on the use of medical cannabis products in different medical conditions and settings to guide the ongoing refinement and development of public health policy
• Public health education programs to continue to educate the public on the harms of extra-medical and risky cannabis-use. 

Keywords: Medical cannabis, medical marijuana, medicines regulation, evidence-based medicine, public health, health protection, health policy, legislation, narcotics, clinical research