Backgrounder [21/1/16]: Medical Cannabis in New Zealand

Peter Dunne

21 JANUARY, 2016

Backgrounder: Medical Cannabis in New Zealand

In light of recent and increasing commentary on the use, access to and funding of cannabis based medical products, attached is a fact sheet on the definition, current availability, status and authorisation process around the use of these products for therapeutic purposes. Further information can be found on the Ministry of health’s website at:http://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/medicinal-cannabis

Status of Medical Cannabis in New Zealand

• Medical cannabis is a blanket term that has different meanings for different people, ranging from the raw plant through to pharmaceutical grade products.

• A variety of claims have been made about the efficacy of cannabis in various forms for a range of medical conditions but there is limited robust evidence to support these claims.

• The wide variety in interpretations of what constitutes medical cannabis can result in confusing and/or inaccurate messaging in the various fora it is reported in, including mainstream media and social media.

• The Government acknowledges that there is a range of views held on what the legal status of cannabis, and cannabis products used for therapeutic purposes, should be.

• The Government’s position is that for cannabis to be used for medical purposes, the same criteria and testing processes as for any other medicine must be met.

• It is up to treating physicians and specialists as to whether they feel the prescribing of any form of cannabis-based products is appropriate, and if so, to follow the processes set out by the Ministry of Health (and summarised below).

Pharmaceutical grade products

• Pharmaceutical grade medical cannabis products can be prescribed in New Zealand subject to ministerial approval under regulation 22 of the Misuse of Drugs Regulations 1977.

• Information on application processes can be found on the Ministry of Health’s website athttp://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/medicinal-cannabis

• Currently the only pharmaceutical grade cannabis product available in New Zealand is Sativex® which is approved for use in multiple sclerosis but is also prescribed for “off-label” uses such as chronic pain, neuropathic pain, cancer pain and intractable childhood epilepsy.

• For pharmaceutical grade products approved for use, ministerial approval has for some years been delegated to Ministry of Health officials.

• Applications must be from a specialist clinician in an appropriate speciality, or from a GP on the recommendation of an appropriate specialist, and are assessed against defined criteria.

Non-pharmaceutical grade products

• For non-pharmaceutical grade products, for example the product Elixinol that was granted ministerial approval for prescribing to an individual in June 2015, ministerial approval is not delegated.

• Applications must be made to the Ministry of Health and be from a specialist appropriate to the medical condition or the Chief Medical Officer of a DHB. Ministry clinicians and officials review applications and provide a recommendation to the Minister.

• Only one application has been received as at 20 January 2016 and a review of its administration by specialists found it achieved no therapeutic effect.

• Criteria have been developed to guide the Minister in case by case consideration of applications and include a severe or life threatening condition, evidence that all reasonable conventional treatments have been trialled and symptoms are still poorly controlled, evidence of risk/benefit analysis by a qualified clinical specialist, the patient is hospitalised when treatment is initiated and a Certificate of Analysis of the product is available. These criteria are for guidance only and are not binding on the Minister.

• These criteria are in place because the use of non-pharmaceutical grade cannabis products is outside current Government policy. There is no evidence for the safety and efficacy of these products and the ad-hoc use of these products does not progress medical knowledge.

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