The Victorian Coalition Government will amend the law in order to facilitate clinical trials of medical cannabis, Minister for Health David Davis said today.
An Expert Advisory Committee, composed of clinical and regulatory experts, would also be appointed to work through the complex issues of obtaining approval to trial the use of cannabis compounds in treating or relieving symptoms for a range of illnesses and conditions, Mr Davis said.
The Drugs, Poisons and Controlled Substances Act will be amended to make it easier to conduct clinical trials involving cannabis and similar highly regulated substances.
Currently, the law requires medical practitioners to seek approval to treat every single patient who might be enrolled in such a trial.
Consideration may also be given to amending the legislation to remove the prohibition on cultivation of narcotic plants for therapeutic purposes in the context of approved clinical trials.
Mr Davis said allowing regulated cultivation for clinical trials in Victoria will help to ensure that the quality of the product being trialled is of an appropriate and assured standard.
“This is the right way forward. Simply declaring something legal doesn’t make it safe. Our approach is grounded in the best available scientific evidence,” Mr Davis said.
“The Napthine Government supports access to pharmaceuticals that are safe and effective, and we commit to removing barriers around safe and effective medications.”
The Therapeutic Goods Administration, the national regulatory body, has already approved one pharmaceutical-grade cannabis extract, marketed as Sativex, for treatment of symptoms of multiple sclerosis. Sativex is an oral spray derived from cannabis grown under controlled conditions.
It will be investigated through a clinical trial in Victoria and other states for treatment of pain in patients with advanced cancer. The Coalition Government supports this and other similar properly structured trials.
“The issues surrounding the use of cannabis compounds for treatment of medical conditions are extremely complex, requiring regulatory and legislative changes, but most importantly, sound medical advice,” Mr Davis said.
“The Coalition Government will work with other authorities to facilitate and support clinical trials of some of these cannabis compounds, while ensuring that they are undertaken in a safe and ethical manner.
“The Coalition Government will support a major Victorian health service importing Sativex and prescribing it as clinically indicated. The health service could also conduct clinical trials for its use to treat other conditions.”
“The Coalition Government will also put the issue on the agenda for the Council of Australian Governments Health Council in October, to ensure, where possible, that co-operative approaches to clinical trials are adopted.
Mr Davis said the Coalition Government would also enable further investigation of the medicinal use of pharmaceutical-grade product containing the cannabidiol compound.
“I will ask the advisory committee to consider the scientific evidence and ethics with a view to further research and trials in Victoria, as suggested by Professor Patrick McGorry,” Mr Davis said.
“If the advice supports this outcome, the Coalition Government will request the Commonwealth to reclassify that particular cannabis compound to allow those trials to take place more easily.
“The Coalition Government gives in-principle support to any properly constructed, ethically approved and appropriately-oversighted trial.”
Mr Davis said the Coalition Government would give in-principle support, subject to proper design, to local involvement in an international trial of Epidiolex.
This product, which will be marketed for the treatment of certain chronic childhood epilepsy conditions, is not yet approved for marketing in any country, but trials are expected next year.