For anyone watching the legislative changes around medicinal cannabis which includes Cannabidiol (CBD) and tetrahydrocannabinols (THC) in Australia the announcement yesterday (August 31st) that changes to the national classification for cannabis scheduling has occurred has been much anticipated. But what does it mean?
What is scheduling?
Scheduling is a national classification system that controls how medicines and poisons are made available to the general public. The scheduling of drugs appears in the Poisons Standard (commonly referred to as the Standard for the Uniform Scheduling of Medicines and Poisons ((SUMP)).
The 2016 medicinal cannabis legislative journey
There have been significant legislative changes around medicinal cannabis in Australia in 2016. This is a fast changing landscape and it is advisable to seek legal professional advice on current licensing requirements. The following is an overview only
In February 2016, the Australian Parliament passed legislation to enable the cultivation of cannabis for medical and scientific use through a licensing scheme to be established under the Narcotic Drugs Act 1967.
Patient access changes
On 12 April 2016, the Victorian Government’s Access to Medicinal Cannabis Bill 2015 was passed by the Victorian Parliament, beginning the process of enabling patients to access medicinal cannabis. This legislation establishes the legal framework for Victorian patients to access locally produced cannabis products with appropriate clinical oversight.
The March 2016 Advisory Committee meeting on medicine scheduling proposed considerable change to the scheduling of cannabis, the discussion was open to public feedback, and we will see the outcome implemented in the November 2016 SUMP.
What is the schedule change?
Historically cannabis has been listed as Schedule 9 entries. Schedule 9 are Prohibited Substance poisons that are drugs of abuse, the manufacture, possession, sale or use of which should be prohibited by law except for amounts which may be necessary for educational, experimental or research purposes conducted with the approval of the Governor.
The use of cannabis, for purposes other than in human therapeutic use, remains in Schedule 9.
The change to the Poisons Standard will amend the existing Schedule 9 entries, and create Schedule 8 entries for cannabis for human therapeutic use.
Schedule 8 are Controlled Drugs, and are prescription medicines which require restriction of manufacture, supply, distribution, possession and use. They are controlled to reduce abuse, misuse and physical or psychological dependence.
The new Schedule 8 entries are specific for human therapeutic use and products are required to be prescribed by a medical doctor that is an authorised medical practitioner.
The authorised prescriber, and whether products containing these substances may be prescribed, may differ between states and territories in Australia.
Prescribed products containing cannabis and tetrahydrocannabinols require sedation warnings.
How will it be accessed?
Cultivation falls the control of the Office of Drug Control and the Narcotics Drugs Amendment Act 2016. Specific licenses are required for cultivation and manufacturing in addition to those required by the TGA to manufacture medicinal products and APIs.
Schedule 8 medicinal cannabis can only be made available on authorised prescription, or by order of an authorised medical practitioner. The authority to prescribe can only be issued by an Australian, State, Territory Health department or agency. This means not all registered medical practitioners can prescribe products containing these substances.
Is this the beginning of a ‘cannabis free for all’?
Changing legislation does not mean that cannabis can now be cultivated by anyone with a green thumb or easily accessed by the general public.
There remains significant legislative and regulatory framework to navigate and at the end of this we need to ensure the products that are reaching patients are safe, of high quality and work.
Which is how it should be.
This is an exciting time for innovators to move into the cultivation and manufacturing space but we need to remember many of the first patients to benefit from these legislative changes are children with severe epilepsy. The tenet of GMP must remain first priority: safety, quality and efficacy. Always.
Would you like to know more about changing landscape of medicinal cannabis in Australia? PharmOut is running an Innovation Dinner, November 15th at the stunning Melbourne Zoo, so please come along.
We will be asking you to arrive at the gate – security guards will escort you to and from the dining venue so that you stay off the grass.