Published: 5 March 2020
Publications
Medicinal Cannabis Scheme: Update from the Ministry of Health
Prescriber Update 41(1): 19-21
March 2020
This article has been provided by the Ministry of Health. It provides an overview of the access of unapproved medicinal cannabis products under the new Medicinal Cannabis Scheme, when the suppliers of these products do not seek consent for distribution (approval) under the Medicines Act 1981.
The Scheme requires products manufactured from the Cannabis plant to meet minimum quality standards, in addition to Medicines Act 1981 requirements for unapproved medicines and Misuse of Drugs Act 1975 requirements for controlled drugs.
Note that the minimum quality standard does not include an assessment of safety and efficacy. For details of what is included in the minimum quality standard, please see the Ministry of Health website.
Medicinal Cannabis Scheme
On 18 December 2019, the government passed the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 to enable the Medicinal Cannabis Scheme. A Medicinal Cannabis Agency will be operational from 1 April 2020 to administer the Scheme.
The regulations enable the establishment of a licensing regime for the cultivation of cannabis for a medicinal purpose and the manufacture and supply of medicinal cannabis products (MCPs) in New Zealand. The regulations also set out a minimum quality standard that all medicinal cannabis products must meet. All medicinal cannabis products must be manufactured under Good Manufacturing Practice (GMP). These requirements will provide prescribers confidence in the quality of the product, which cannot be ensured for all other unapproved medicines.
From 1 April 2020 there will be a 6-month transition period where the supply of MCPs already available will continue under current licences to ensure that patient access is maintained. Current suppliers of MCPs will have until 1 October 2020 to submit their existing product for an assessment against the medicinal cannabis quality standard.
Products that have already obtained Medsafe consent for distribution under the Medicines Act 1981 (ie, Sativex) and any future product which obtains this, are not required to meet the medicinal cannabis quality standard (see below).
Changes to prescribing
The regulations introduce significant changes to the prescribing of MCPs in order to minimise barriers and improve access. Once a MCP has been assessed by the Medicinal Cannabis Agency and has been verified as meeting the quality standard, it can be prescribed by any medical practitioner. Ministerial approval and specialist recommendation will not be required.
We expect suppliers of already available products to apply for assessment of their products during the 6-month transition period so that supply can continue after 1 October 2020. The Medicinal Cannabis Agency will be accepting applications from companies for product assessments from 1 April 2020.
A list of MCPs which meet the quality standard will be made available to prescribers and other health care professionals.
Prescribing requirements
MCPs, except cannabidiol (CBD) products, are controlled drugs under the Misuse of Drugs Act 1975. CBD products are prescription medicines under the Medicines Act 1981.
With the exception of Sativex1 (see below), all MCPs available in the immediate future will be unapproved medicines – that is, they will not have consent for distribution under the Medicines Act 1981. Prescribers should be familiar with the requirements for prescribing unapproved medicines and Medsafe guidance on the topic2.
Products should be prescribed by brand and prescriptions should not permit generic substitution. A medicinal cannabis product must not be in a form intended for smoking, a food or be a sterile dosage form (eg, eye drops).
Cannabidiol (CBD) products
CBD products primarily contain cannabidiol and little to no tetrahydrocannabinol (THC) and other related psychoactive substances (Section 2A of the Misuse of Drugs Act 1975 has a specific definition of a CBD product3).
These products will be in a pharmaceutical dosage form such as a capsule or oral liquid.
CBD products which are currently available can continue to be prescribed and supplied after 1 April 2020. However, suppliers will need to provide evidence of products meeting the quality standards to continue supplying them after 1 October 2020.
Other medicinal cannabis products (excluding CBD products)
Because other MCPs (ie, excluding CBD products) are controlled drugs, additional requirements for prescribing controlled drugs apply, including handwritten prescriptions on a controlled drug prescription form for a quantity not exceeding a 1-month supply.
Other MCPs may be in a pharmaceutical dosage form or as dried flower intended for vapourisation.
Products which do not meet the minimum quality standard
If a medicinal cannabis product does not meet the minimum quality standard or has not yet been assessed by the Medicinal Cannabis Agency there will still be pathways available to prescribe it.
- CBD products will only be able to be prescribed by a medical practitioner and imported directly for the named patient by the medical practitioner or a pharmacy on behalf of the medical practitioner.
- Other medicinal cannabis products (ie, controlled drugs) that have not met the quality standard will only be able to be prescribed with Ministerial approval and specialist recommendation. They will have to be imported directly by the medical practitioner or pharmacy on behalf of the medical practitioner to supply to the named patient.
Ministerial approval to prescribe for named patients, obtained prior to 1 April 2020, will continue to be valid until it expires.
Products consented for distribution (approved) under the Medicines Act 1981
Any medicinal cannabis product that gains consent to distribute under the Medicines Act 1981 is required to meet Good Manufacturing Practices (GMP) and will have been assessed and met the standards of quality that apply to medicines. These products will therefore not be required to meet the medicinal cannabis quality standard.
Sativex is currently the only medicinal cannabis product that has consent for distribution under the Medicines Act 1981 – meaning it has been assessed for safety and efficacy for its approved indication, in addition to manufacturing quality. From 1 April 2020, Sativex can be prescribed without Ministerial approval or specialist recommendation for any indication (ie, both on-label and off-label).
More information
For more information on the Scheme, see the Ministry of Health website.
Further information and guidance will be published as it becomes available.
References
- Emerge Health New Zealand Limited. 2017. Sativex New Zealand Data Sheet February 2017. URL: medsafe.govt.nz/profs/Datasheet/s/sativexspray.pdf (accessed 23 January 2020).
- Medsafe. 2014. Use of Unapproved Medicines and Unapproved Use of Medicines. URL: medsafe.govt.nz/profs/RIss/unapp.asp (accessed 23 January 2020).
- New Zealand Legislation. Misuse of Drugs Act 1975. 2A Meaning of a CBD product. 13 August 2019. URL: legislation.govt.nz/act/public/1975/0116/latest/DLM436101.html#LMS148483 (accessed 24 January 2020).
