Medicinal cannabis trials
On 19 April 2015, the Premier announced that Queensland will partner with New South Wales (NSW) in trials of medicinal cannabis.
The trials will explore the development and use of safe, pharmaceutical product(s) derived from cannabis to treat particular medical conditions; such as children with severe, drug-resistant epilepsy.
The design and detail of the trial relating to Queensland’s involvement is yet to be agreed. Discussions are still occurring with NSW to work this out. It is anticipated the trial will begin in 2016.
Clinical trials take time and are resource intensive. There are stringent quality and efficacy standards that must be met to undertake clinical trials involving people.
Any pharmaceutical preparation derived from cannabis or cannabis products must go through the necessary rigorous process to prove their safety and effectiveness before they can be used in human trials.
The trial will assist in developing a pharmaceutical product that is safe and consistent in its dosage to allow for testing of its effectiveness in treating certain medical conditions.
Queensland has agreed to partner in the NSW trials.
This partnership may be in a variety of ways such as in the development of research design, clinical support and participant involvement.
Initial participation in the NSW trials is expected to be aimed at children with severe, drug-resistant epilepsy who meet the criteria for inclusion in the trial.
The trial is likely to begin in 2016. Once the trial start date is known, entry and eligibility details will be released publicly.
Individuals, including parents and carers of potential trial participants should maintain close contact with their general practitioner and other medical supports to ensure they receive the best medical care currently available in Queensland. Your treating doctor will also be able to keep you informed about medicinal cannabis trials as matters progress.
Developing a pharmaceutical product derived from cannabis
Currently, Australia does not have a pharmaceutical product derived from cannabis suitable for testing or trialling.
Research is underway to develop a safe, pharmaceutical product derived from cannabis to trial, and ultimately be used to treat particular severe health conditions.
This is similar to the way the opium poppy plant was researched and trialled to develop pharmaceutical products, including morphine.
As part of the NSW trial, a pharmaceutical product that is high in cannabidiol (CBD) and low in tetrahydrocannabinol (THC) is expected to be developed.
CBD is the active component in cannabis that has potentially therapeutic effects for patients for certain conditions. Some effects have been shown in early, but inconclusive research trials conducted overseas.
THC is the psychoactive component of cannabis that is associated with its psychoactive effects that can cause harm, particularly in young people.
Crude cannabis and cannabis oil remain illicit substances in Queensland.
Regulation and legality of cannabis
The Queensland Government has not committed to legalise cannabis. The use of cannabis, no matter what the motive remains illegal.
There is a significant difference between the use of regulated pharmaceutical products for medical treatment and using crude cannabis products for recreational purposes.
It is anticipated that participants in the NSW trial will be using pharmaceutical medicinal cannabis products approved by the Commonwealth Government’s TGA (Therapeutic Goods Administration). Such pharmaceutical products will be able to be lawfully used and not considered illegal under provisions of the Drugs Misuse Act 1986.
Australia has an extremely good system of managing and regulating medicines that strives to keep everyone safe and ensure that new medicines are effective in treating particular conditions and properly assessed before being allowed for wider use.
All products that are for human therapeutic use in Australia have to meet the same stringent quality and efficacy standards as all other medicines that are used.
There is no amnesty for growing, supplying or using cannabis in Queensland.
Supply of cannabis
The quantities of cannabis needed for the NSW trial are expected to be very small. NSW will organise the supply of any products it needs to create a safe, pharmaceutical product derived from cannabis for the trial.
For more information, visit NSW Health website