Medicinal Cannabis Scheme

The Medicinal Cannabis Scheme (MCS) regulations were passed by Cabinet on December 18th, 2019. The regulations came into force on April 1st, 2020. The regulations:

• impose a minimum quality standard for medicinal cannabis products and related material and ingredients; and

• provide for medicinal cannabis licences that authorise various activities relating to medicinal cannabis products and related material and ingredients.

Objective of the MCS

The primary objective of the MCS is to increase access to quality medicinal cannabis products. Government intervention is required to establish a regulatory scheme for the commercial production and import of products under licence. Regulations specific to medicinal cannabis will set minimum quality standards for products and set out a licensing regime.

Expected benefits of the MCS

The main expected beneficiaries are patients, health practitioners, medicinal cannabis cultivators, manufacturers and suppliers. Products regulated under the scheme will be made to a quality standard with a known composition (ie ratio of THC / CBD).

Now that the scheme has come into force doctors continue to be able to prescribe CBD products and will also be able to prescribe products containing THC without the need for Ministry of Health approval. Products containing THC will need to be approved medicines or assessed by the MCS as meeting the minimum quality standard.

The transitional arrangements whereby products imported into New Zealand under the old regulations could continue to be supplied ended on September 30th, 2021. Since October 1st 2021, all medicinal cannabis products imported into or manufactured in New Zealand must be verified as meeting the medicinal cannabis Minimum Quality Standards (MQS) before they can be supplied.

Misuse of Drugs Amendment Act

The Misuse of Drugs (Medical Cannabis) Amendment Act came into law on December 17th, 2018 in New Zealand. It introduced an exception and a statutory defence for terminally ill people to possess and use illicit cannabis and to possess a cannabis utensil; provided a regulation-making power to enable the setting of standards that products manufactured, imported, and supplied under licence must meet; and amended Schedule 2 of the Act so that cannabidiol (CBD) and CBD products are no longer classed as controlled drugs.

Use of cannabis in palliation

In the Act, a person requires palliation if, in the opinion of a medical practitioner or nurse practitioner, the person has an advanced progressive life-limiting condition and is nearing the end of their life.

A person who has a certificate from a medical practitioner or nurse practitioner certifying that the person requires palliation may procure, possess, consume, smoke, or otherwise use any plant or plant material of the genus Cannabis or any cannabis preparation. They may also possess a pipe or other utensil (not being a needle or syringe) for the purpose of possessing or using any plant or plant material of the genus Cannabis or any cannabis preparation.

People who do not have evidence at the time of questioning about possession and use of illicit cannabis, but can produce evidence from a medical practitioner or nurse practitioner that they require palliation in Court, will have a defence against conviction.

How to certify a person requires palliation

The Ministry of Health defines the certification as a written statement that in the medicinal or nurse practitioners’ clinical opinion, the patient meets the definition of palliation in the Act. The certification is not an endorsement of the use of illicit cannabis.

There is no prescribed template for certification in the Act. The documentation could be in the form of a letter and needs to contain: the patient’s name and address, the practitioner’s name, address and Medical Council/Nursing Council number, the date that the patient was seen and a statement that s/he requires palliation as defined by the Act.

The Act does not specify a requirement to renew certification, however the Ministry of Health recommends patients’ certification are renewed every 12 months.

What is a CBD Product?

With the passing of the Misuse of Drugs (Medical Cannabis) Amendment Act some products containing Cannabidiol (CBD) are now regulated as prescription medicines and are no longer controlled drugs.

CBD Product Definition

Cannabidiol (CBD) is a substance found in cannabis that has potential therapeutic value, which unlike THC, has no intoxicating psychoactive properties. With the passing of the Act noted above CBD is no longer a class B1 controlled drug. This means Ministry of Health approval is not required to to prescribe, supply or administer products for medical purposes if they meet the following definition.

A product is deemed a CBD product if it contains 98% or more CBD. Consequently the amount of tetrahydrocannabinols (THC) and psychoactive related substances must not exceed 2% of the total CBD, tetrahydrocannabinol and psychoactive related substances content in the product. In addition it must not also contain any other controlled drug or psychoactive substance.

Importing CBD products

Pharmacies, authorised prescribers and licensed wholesalers of medicines are able to import CBD products, without an import licence. It is important to note that this applies only to CBD products as defined above. Many products that can readily be found for sale on international websites do not meet this definition as the percentage of THC is too high.

These products are controlled drugs and cannot be legally imported without a licence to import a controlled drug issued by Medicines Control at the Ministry of Health and a licence to export from the exporting country.

Unapproved Medicines

The Medicines Act 1981 permits an authorised prescriber to prescribe, administer or arrange for the administration of medicines for the treatment of a patient in his or her care. The medicine and its use may or may not be approved. The Act also permits the sale or supply of unapproved medicines to registered medical practitioners, but requires the supplier to notify the Director-General of Health.

Use of unapproved medicines - Section 25

The need to provide for access to unapproved medicines was recognised when the Medicines Act was formulated. Section 25 of the Act permits authorised prescribers to procure, administer and arrange the administration of an unapproved medicine. Section 29 permits the sale or supply of an unapproved medicine to a medical practitioner for the treatment under that medical practitioner’s care provided the Director-General of Health is notified of that supply.

Section 25 permits an authorised prescriber to use any medicine (approved or unapproved) for the treatment of a particular patient in his or her care. The Act puts no restriction on the use of a medicine, even in a situation in which it is contraindicated. However, whether the authorised prescriber uses approved or unapproved medicines, he or she must provide care of an adequate professional and ethical standard. This is covered in detail in Consumers’ Rights.

Sale or supply of unapproved medicines - Section 29

Section 29 of the Act permits the sale or supply to medical practitioners of medicines that have not been approved, and requires the "person" who sells or supplies the medicine (usually a pharmaceutical company or distributor) to notify the Director-General of Health of that sale or supply in writing.

This means that pharmaceutical suppliers most hold the following information in every case and retain the records as available for audit by the Ministry of Health:

• the name(s) of the medical practitioner(s) who requested the supply of the medicine

• the name(s) of the patient(s) the medicine was required for

• the INN / generic name and trade name of the medicine

• the dose form(s), pack size(s) and strength(s) of the medicine

• the quantity supplied

• the date(s) of the month and year the medicine was supplied

• the name(s) of the place(s) the medicine was supplied to 

Consumers’ Rights

The Code of Health and Disability Services Consumers' Rights (the Code) establishes the rights of consumers, and the obligations and duties of providers to comply with the Code. Two of these rights have particular relevance for the use of unapproved medicines.

Right to services of an appropriate standard

1. Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.

2. Every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of, that consumer.

Whether the medicine or use of the medicine is approved or unapproved, the practitioner must approach the decision for its administration in a professional, scientific manner which includes weighing the expected benefits and risks.

This right also applies to the situation where a patient requests the prescription of an unapproved medicine about which the practitioner knows nothing. In such cases, the practitioner must seek to be adequately informed before assisting the patient to obtain supplies of the medicine. 

This is particularly relevant for medicinal cannabinoid products since suppliers cannot legally promote products and can only reply to requests for information from practitioners.

Right to be fully informed

1. Every consumer has the right to the information that a reasonable consumer, in that consumer's circumstances, would expect to receive, including—

(a) an explanation of his or her condition; and

(b) an explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and

For an unapproved medicine or unapproved use, the patient should be advised of the unapproved status. The patient should also be advised of the degree and standard of the support for the use of the medicine, and of any safety concerns, or warnings or contraindications regarding its use in their particular condition. In using the phrase "Right to be fully informed", the Code requires frank disclosure of information including information that may dissuade the patient from agreeing to use of the medicine.

You can find plenty of information on medicinal cannabinoids online but little of it is accurate and balanced. We provide links to all our sources in the body of each section. Below you will find a summary for our Legislation section.

Medical Cannabis Amendment Act

1. Medical Cannabis Amendment Act (http://www.legislation.govt.nz/act/public/2018/0054/21.0/DLM7518707.html)

2. Letter for patients certify palliation required template (https://www.health.govt.nz/system/files/documents/pages/medicinal-cannabis-letter-for-patients.docx)

CBD Products

1. CBD Product Definition (https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/medicinal-cannabis/prescribing-medicinal-cannabis-products#1)

2. More about CBD Products (https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/medicinal-cannabis/cbd-products)

Unapproved medicines

1. Use of unapproved medicines (https://www.medsafe.govt.nz/profs/RIss/unapp.asp)

2. Section 29 Declaration Form for use by suppliers (https://www.medsafe.govt.nz/downloads/sect29.doc)

Consumers’ Rights