Australian-made cannabis no free-for-all
Access to cannabis for medicinal purposes will be tightly controlled and subject to rigorous scientific assessment even as the country moves to legalise and license its cultivation.
Health Minister Sussan Ley has confirmed that medical cannabis will only be available by prescription, and its use will be subject to approval by the Therapeutic Goods Administration.
Advocates have welcomed Federal Government plans to introduce legislation allowing the controlled cultivation of cannabis for medical and scientific purposes by the end of the year.
But Ms Ley cautioned that although the new laws, which have the support of Labor, would legalise and regulate the production of medicinal cannabis, any potential application would need to be approved by the medicines watchdog based on evidence as to safety and efficacy.
“It’s important we maintain the same high safety standards for medicinal cannabis products that we apply to any other medicine,” the Health Minister said. “I’m sure Australians would be concerned if we allowed medicinal cannabis products to be subject to lower safety standards than common prescription painkillers or cholesterol medications.”
The AMA has argued that cannabis should be regulated in the same ways as other therapeutic narcotics, and be subject to rigorous testing to assess its clinical safety and effectiveness for various conditions.
AMA President Professor Brian Owler said last year that the efficacy of medicinal cannabis for treating symptoms of multiple sclerosis was well established, but other applications should be subject to the same rigorous assessment process as applied to other medicines.
“The way that we regulate medicines in this country for clinical indications is through the TGA, and I think we need to keep using those mechanisms…to regulate the availability of cannabis – not crude cannabis that can be grown at home, but the pharmaceutical preparations that are actually already available, and even looking at putting those on the PBS for particular indications,” the AMA President said.
The Health Minister said medicinal cannabis would not be made available over the counter, except through a doctor’s prescription or as a result of evidence gained through clinical trials.
“At the end of the day, cannabis is classified as an illegal drug in Australia for recreational use and we have no plans to change that,” Ms Ley said. “In many cases the long-term evidence is not yet complete about the ongoing use of various medicinal cannabis products, and it’s therefore important we maintain the role of medical professionals to monitor and authorise its use.”
The Government has proposed the Health Department operate a national licensing scheme to allow the controlled cultivation of cannabis, providing what Ms Ley said was the critical “missing piece” in enabling a sustainable domestic supply of safe medicinal cannabis for Australian patients.
While there are already systems in place to license the manufacture and supply of medicinal cannabis products, local production is currently illegal, and patients and carers trying to obtain them have been forced to try illegal suppliers or to overcome numerous barriers to access on international markets.
“Allowing the cultivation of legal medicinal cannabis crops in Australia under strict controls strikes the right balance between patient access, community protection and our international obligations,” Ms Ley.
The Government will consult with Labor, the Australian Greens, crossbench senators and the states and territories before introducing a final version of the proposed legislation to Parliament by the end of the year.
Ms Ley said the proposed Commonwealth licensing scheme would set out universal obligations and a common legislative framework for states looking to allow medicinal cannabis cultivation.
“It’s imperative we have a clear national licensing system to ensure we maintain the integrity of crops for medicinal or scientific purposes,” she said. “It allows us to closely manage the supply of medicinal cannabis products from farm to pharmacy. We also want to make sure that this approval and monitoring process for cultivation isn’t fragmented across different jurisdictions and provides regulatory consistency.”
But the Greens, though welcoming the Government’s move, argued that it did not go far enough.
Greens leader Dr Richard Di Natale said the proposed legislation did nothing to remove the “bureaucratic barriers” he argues will prevent it from being prescribed like other medicines.