The Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021 was introduced to the Commonwealth Parliament on Wednesday (February 3rd).
If passed, it will make a number of changes to Australia’s commercial medicinal cannabis framework. Most notably:
• Replace the current three licence types (cultivation, manufacture and research) with a single licence.
• Remove licence expiry and renewal requirements, making them perpetual (unless revoked or surrendered).
• Shift some information requirements from the initial licence stage to the permit stage.
• Introduce a statement of purpose to the Narcotic Drugs Act clarifying that it is designed to “make medicinal cannabis products available for therapeutic purposes”.
The bill is the culmination of an extensive period of regulatory design and industry consultation.
The changes are informed by the recommendations of John McMillan AO in his review of the Narcotic Drugs Act, which was published in September 2019.
Since 2016, when the framework was first implemented, industry members have encountered a number of challenges with the licence and permit scheme.
Some organisations have had applications pending for more than two years, and industry members have reported delays, inconsistencies, and an overall lack of transparency in the process.
This has made it harder, more expensive, and riskier for Australian companies to cultivate and manufacture medicinal cannabis and delayed the widespread availability of affordable, Australian-made products.
Fixing the issues with the licensing system by making it easier for companies to operate should translate into higher-quality and lower-cost medicines for Australian patients.
However, this is just the first step in what remains a long-term project. The bill will first need to pass the Senate, which is considered very likely, and new regulations will need to be implemented.
It will also not be an easy job for the ODC to implement. Overhauling entire business processes, drafting and issuing new guidance documents, and making it all work will be challenging.
But it is hoped the industry will end up with a simpler, clearer, and easier to manage framework.