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Correcting the record: Australian Financial Review story on medicinal cannabis
This TGA behind-the-news article was published on 7 December 2016. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.
On 5 December 2016, the Australian Financial Review ran a story 'Lambert-backed medicinal cannabis grower leaves for the US'. The story is inaccurate, despite the AFR seeking and receiving factual comment from the Department of Health before publication.
'Australia's largest medicinal cannabis grower'
Ecofibre, the 'Lambert-backed medicinal cannabis grower' of the headline, is not a 'medicinal cannabis grower'. Ecofibre has never held a licence to cultivate medicinal cannabis. No commercial company has yet been licensed to grow cannabis for medicinal purposes under legislation that commenced on 30 October; however, the Department of Health is now taking and assessing applications.
Ecofibre is a licensed industrial hemp grower. Industrial hemp growers are licensed by states or territories and not the Commonwealth.
'...manufacturer...who is supplying to specific approved users'
Manufacturers do not have to demonstrate that they have specific patients before they can be licensed. Rather, they need to demonstrate good business planning that shows they understand their potential markets.
It is true that cultivators need to name the manufacturer they are growing for when applying for a licence. It is not unreasonable to expect a cultivator to know who they are growing for.
'...it is almost impossible to get permission to use [medicinal] cannabis'
Under Commonwealth legislation, it has been possible for many years for patients to access medicinal cannabis products. Since the announcement of the medicinal cannabis framework, the Therapeutic Goods Administration has received - and approved - an increasing number of requests for medicinal cannabis products.
The Department of Health anticipates that there will be many more requests from doctors as they become more aware of the potential benefits of medicinal cannabis and domestically cultivated and manufactured product becomes available. The Department has employed additional staff to cope with the expected surge in demand.
'In the US growers are licensed to operate anywhere in that country and can then look for markets, including for export to Australia'
The United States' Drug Enforcement Agency (DEA) is responsible for issuing export permissions for particular drugs.
According to this factsheet, the DEA classifies cannabis as a Schedule 1 Drug, which means it has 'a high potential for abuse, no currently accepted medicinal use in treatment in the United States, and a lack of safety for use of the drug or other substance under medical supervision'. The cultivation of medicinal cannabis is illegal under Federal law in the United States unless approved by the DEA. The DEA has only approved one cultivator to grow cannabis for use in Food and Drug Administration authorised research purposes. In August this year, it announced its intent to register more, to foster research.
Some states have legalised the cultivation of cannabis for medical purposes. However, this is in contravention of Federal law and the licensed growers can only operate in the state that issued the licence.
The Department of Health's understanding is that the DEA will not issue export permission for medicinal cannabis at this time, and the Australian government will not permit the import of medicinal cannabis without DEA approval of the export.
Further information on the DEA's stance on cannabis can be found at: The DEA Position on Marijuana.
'...medicinal cannabis must be grown in costly high-security glasshouses'
Cannabis cultivated for medicinal purposes can be grown outdoors.
This cultivation is subject to security provisions to prevent diversion; however these security provisions are risk-based.
Where there is a high risk of diversion, such as where the cannabis contains high levels of THC, the psychoactive substance in the plant, then the security requirements will be higher.
Where there is a low or negligible risk of diversion, such as for cannabis with low THC and high CBD, the chemical thought to be responsible for the effects of cannabis on childhood epilepsy, then the security requirements can be applied at a much lower level of rigour.
'...no state governments have fully legalised the use of medicinal cannabis'
The use of medicinal cannabis can be approved in all Australian states and territories.
There were legal problems in accessing medicinal cannabis products in some state and territories; however, the Department of Health and the states and territories have worked collaboratively during 2016 to address these issues.
'...because of Australia's tight laws the cannabis used in the NSW [clinical] trials on humans has to be imported'
The clinical trials in New South Wales were announced in 2014. The researchers sought products of suitable quality and standardisation lawfully produced overseas because at that time, there were no domestically grown and cultivated medicinal cannabis products available, since the scheme did not commence until 30 October 2016. As cultivators become licensed, Australian product will become available for clinical trials. The Department of Health has talked with several prospective producers who hope to focus their cultivation activities on clinical trial research.