Medicinal Cannabis

By October 19, 2015 Recent News

Ministry of Health October 2015
What is Medicinal Cannabis?
The term medicinal cannabis encompasses several types of products containing extracts of the cannabis plant that may be used to treat various medical conditions.

Cannabis products are Class B1 controlled drugs and Ministerial approval is required before these can be prescribed, supplied or administered, in accordance with regulation 22 of the Misuse of Drugs Regulations 1977.

Please note that the Government does not support the use of unprocessed or partially processed cannabis leaf or flower preparations for medicinal use.

There are three types of medicinal cannabis products that may be considered for Ministerial approval:
1. Pharmaceutical grade cannabis products that have consent for distribution in New Zealand. Consent for distribution means that the product has been determined by Medsafe to meet acceptable safety and efficacy requirements for distribution in New Zealand. The only product meeting this criterion currently is Sativex® for the treatment of multiple sclerosis. It may also be prescribed as a non-consented product for some other medical conditions.
2. Pharmaceutical grade products that do not have consent for distribution in New Zealand, for example a product that has been manufactured by a pharmaceutical company overseas.
3. Non-pharmaceutical grade products, that is products that are not manufactured to internationally recognised pharmaceutical manufacturing standards.They may, or may not, have been intended to be used as medicines.

Criteria used to Guide the Assessment of Applications for Ministerial Approval to Prescribe, Supply and Administer
The criteria used to guide decisions on Ministerial approval to prescribe, supply or administer these products are listed below. There are separate application forms for each category.
If you require further information as to the appropriate form to use for an application for Ministerial approval to prescribe a medicinal cannabis product please email: medicinescontrol@moh.govt.nz.

1. Pharmaceutical grade cannabis products that have consent for distribution in New Zealand
More information on Sativex® and the application process to prescribe Sativex® for multiple sclerosis or “non-consented conditions” can be found on the Medsafe website(medsafe.govt.nz)

2. Pharmaceutical grade medicinal cannabis products that do not have consent for distribution in New Zealand
The criteria used to guide Ministerial approval are:
a. application from an appropriate specialist
b. a manufacturer has demonstrated a commitment to the development of the product as a pharmaceutical or the product has been prepared pharmaceutically and the characteristics and formulation are clearly described and defined
c. the product has completed animal studies demonstrating proof of concept and potential clinical benefit
d. the product is undergoing an appropriately designed Phase II clinical study or the product has completed clinical trials and is marketed overseas but is not approved for distribution in New Zealand
e. the product is available for use
f. evidence that there will be close follow up of patient by a prescriber
g. evidence that a wide range of conventional treatments have been trialled and symptoms are still poorly controlled
h. condition is one for which there is some evidence of efficacy, preferably in clinical trials
i. no history of abuse or diversion of controlled drugs
j. the patient has no known contraindication to the use of the product
k. initial approvals usually for 6 months
l. baseline clinical indicators generally required and evidence of improvement is required before a new approval is given.

3. Non-pharmaceutical grade medicinal cannabis products
The criteria used to guide Ministerial approval are:
a. severe or life-threatening condition
b. evidence that all reasonably applicable conventional treatments have been trialled and the symptoms are still poorly controlled
c. evidence that the risk/ benefit of the product has been adequately considered by qualified clinical specialists – that is, the risk of treatment with an unproven product is less than the risk of non-treatment and account has been taken of any evidence of potential benefit and weighed against known adverse effects
d. patient hospitalised when treatment is initiated
e. patient or guardian has provided informed consent
f. application from a specialist appropriate to the medical condition being treated or the Chief Medical Officer of a District Health Board
g. applicant or specialist prescriber has sought adequate peer review eg, Hospital Ethics Committee approval, Drug or Therapeutics Committee review
h. provision of a Certificate of Analysis, preferably from an accredited laboratory, so that the concentration of the active ingredient(s) is known
http://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/medicinal-cannabis