New Zealand has now launched its Medical Cannabis Scheme, designed to help patients gain better access to cannabis medicines. If you're wondering exactly what the new regulations mean for you, we've prepared a summary to answer all your questions.
On the 1st of April 2020, the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 were enacted, and subsequently New Zealand's Medicinal Cannabis Scheme went live. The Ministry of Health created a Medicinal Cannabis Agency to administer the Scheme and ensure medicinal cannabis products meet the country's quality standards.
These regulations have been established specifically to improve patient access to quality medicinal cannabis products.
To achieve this, the Scheme allows any doctor to prescribe medicinal cannabis products to any patient, for any condition. The supply of products will also be increased by establishing a licensing regime, enabling the commercial cultivation of cannabis in New Zealand and the manufacture and supply of medicinal cannabis products made to quality standards.
For the Scheme to be successful, it must deliver quality products to patients and be commercially sustainable. This is where licensed, locally-owned medicinal cannabis producers, such as Helius, come in.
Speaking in December when the scheme was announced, Health Minister, Dr Davis Clark said: “Many New Zealanders will have watched a loved one struggle with chronic pain, particularly near the end of their lives. Medicinal cannabis products can make a real difference to people’s quality of life".
“These regulations put in place the infrastructure that allows us to locally grow, manufacture and provide quality medicinal cannabis products that are intended to make a real difference to people living in pain, and also those nearing the end of their lives,” say Dr Clark.
What type of products are covered by the Scheme?
The Scheme covers cannabis products originating from the cannabis plant for medicinal use. It does not cover medicinal cannabis products manufactured from synthetic cannabinoids or cultivating and manufacturing cannabis products for non-medical use. The latter is the domain of New Zealand's Cannabis Legalisation & Control Bill.
CBD (cannabidiol) products may be prescribed by any doctor registered to practice in New Zealand. These are classified as 'Prescription Medicines', providing the content of THC (or other cannabinoids) does not exceed 2% of the total active ingredients.
There are already a small number of CBD products available in New Zealand. Unfortunately, the cost of these products remains high, but patients can expect prices to fall as soon as locally-made alternatives come to market over the next 12 months.
THC and other cannabinoids
Medicinal cannabis products containing more than 2% THC (tetrahydrocannabinol) can also be prescribed by any doctor, providing the Medicinal Cannabis Agency has verified the product meets the minimum quality standards. These products are classified as 'Controlled Drugs'.
This includes medicines featuring other cannabinoids, such as THCV, CBG, and CBN, when the become available.
Products that have been assessed for safety and efficacy (though clinical trials) and been consented for distribution under the Medicines Act 1981, can be registered as 'Approved Medicines'. Presently, the only approved cannabis medicine in New Zealand is Sativex™, however many patients consider this product cost prohibitive.
If a patient wishes to access a THC product that has not been verified to meet New Zealand's minimum quality standards (for example, if you wish to import a cannabis product from another country), then ministerial approval is required. Approval of a named patient can be granted by the Minister of Health following a recommendation from a relevant medical specialist or the Chief Medical Officer of a District Health Board. Approvals can only be facilitated by a doctor, through the Medicinal Cannabis Agency.
Are legal cannabis producers established in New Zealand?
Yes. There are about a dozen licensed producers in New Zealand at this time, the largest of which is Helius Therapeutics in Auckland. Some are focused solely on cultivation. Others, like Helius, are vertically integrated, which means the company grows, drys, extracts, processes, manufactures, packs and distributes its own-branded cannabis medicines.
Companies must apply to the Medicinal Cannabis Agency to become licensed to cultivate, process or possess medicinal cannabis. To produce finished medicines, they must also be Good Manufacturing Practice (GMP) certified and hold a License to Manufacture Medicines from the Ministry of Health.
For you are interested in a career in New Zealand's cannabis industry, you'll either need to gain a medicinal cannabis license or work for a company who has one. If you're interested in working with Helius, you can register here.
What dose formats will be available?
Today, there are just three medicinal cannabis dose forms available in New Zealand. These are oral liquids (a tincture taken under the tongue), lozenges and capsules. However, the Scheme allows for a wide range of other dose types to be introduced over time.
New dose forms
Any type of medicinal cannabis product can be developed and made available to patients in New Zealand, providing the dose form has a monograph in the European Pharmacopoeia, and the product has been assessed and registered by the Medicinal Cannabis Agency.
Future dose forms in New Zealand could include inhalers, transdermal patches, or even heal teas, and more. But these must all be assessed by the Medicinal Cannabis Agency and meet the minimum quality standards.
Good Manufacturing Practice (GMP) certification
Products must also be European (EU) or New Zealand GMP certified from the point of extraction, right the way through to manufacturing and packaging. This is a high quality standard and, at this point in time, very few international producers (and no local producers) can meet these requirements. Again, this is set to change as local companies, like Helius, earn GMP certification.
Cannabis-derived active pharmaceutical ingredients (APIs) only
The regulations require that all active ingredients must be cannabis-derived. This means that medicinal cannabis producers cannot presently combine active pharmaceutical ingredients (such as CBD and Kawakawa).
Dry flower and herbal vaporisers
Cannabis flower (dry flower) products will be permitted under the Scheme, though none are yet available in New Zealand. These must be intended for administration through an approved medical vaporiser. A vaporiser can be imported and sold only if it has been approved as a medical device by an overseas regulator. This ensures the vaporiser will be a safe method for administering medicinal cannabis.
Other vaporiser devices, and utensils with prohibited features, continue to be prohibited from New Zealand and may be confiscated by Customs.
Edibles are not permitted
Overseas, edible forms of medicinal cannabis are popular, However, in New Zealand medicinal cannabis products must meet the definition of ‘food’ under the Food Act 2014. This rules out chewable gummies and other similar dose forms.
When will New Zealand made products be available?
Right now, all medicinal cannabis products in New Zealand are imported. A range of New Zealand made medicinal cannabis products will become available over time as local producers are granted new commercial licenses.
Previously, all local companies have been restricted to research activities only. Commercial applications just became available in April 2020 and we expect the first of theses licenses to be granted around July 2020.
Companies will also need to gain GMP certification. Products then need to go through a drug development process, which involves equipment and process validation and gathering of stability data to determine a product's shelf life. This can take 12 months or more, depending on the product.
Once a company holds a commercial medicinal cannabis license, and has validated their product, it can apply to the Medicinal Cannabis Agency to assess whether their products meet the medicinal cannabis minimum quality standard. Applications for product assessments opened on 1 April 2020.
The industry is working hard to get locally-made products to market. In the meantime some producers, including Helius, plan to import products, made to their specification. While we are waiting for local facilities to come online, this is a helpful solution as it increases the product options available in New Zealand. More competition also helps to lower prices for you, the consumer.
You should expect New Zealand grown and manufactured cannabis medicines to available to patients in late 2020 or early 2021. Exact timing will depend on how quickly the Medicinal Cannabis Agency is able to grant licenses and issue new product registrations.
Can patients import cannabis products from overseas?
Personal imports of medicinal cannabis products are not allowed. All medicinal cannabis products must be dispensed by a doctor or a pharmacy.
How much do medicinal cannabis products cost?
Currently, medical cannabis patients in New Zealand can only access cannabis products sourced from other countries. This can be extremely costly for the patient.
At the time of writing, based on data from patient anecdotes, the average cost for an imported 100mg/ml CBD product in a 30ml oral solution ranges from $200 – $300, which is typically one month's supply. A balanced product with 10mg/ml of THC and 10mg/ml of CBD in a 30ml oral solution ranges from $120 – $150. Sativex™ is reported to cost between $800-$1200 a month. These prices are indicative only; they have been coming down over the last 24-months and vary between pharmacies.
The good news is that product costs are expected to come down significantly, as the new Medicinal Cannabis Scheme enables production of cannabis medicines here in New Zealand.
Medicinal cannabis products are private medicines, which means they're not funded by Pharmac. It's possible that a product could become funded in the future, but we expect that would be several years away. In the meantime, Helius is working on a program to self-fund medicinal cannabis for those most in need. We call this initiative Helius Assist, and you can read about it here.
Who can prescribe?
Any doctor registered to practice in New Zealand is able to prescribe medicinal cannabis products to you without additional oversight, and for any condition. Unlike some other countries, there is no list of ‘qualifying ailments’. Doctors are free to make their own assessment and can prescribe registered medicinal cannabis products at their own professional discretion.
Prescriptions for medicinal cannabis products will specify the brand and prohibit any generic substitutions.
Can I get a prescription with repeats?
Prescriptions for CBD products, or cannabis products that are ‘approved medicines', must be for no more than a 3-month supply.
Other medicinal cannabis prescriptions, such as non-approved products containing THC or other cannabinoids, must be handwritten on a controlled drug prescription form and be for no more than a 1-month supply.
Can I travel overseas with medicinal cannabis products?
Entering New Zealand
You may bring a medicinal cannabis product into New Zealand if its has been prescribed to you by a doctor. It's advisable to have a copy of the prescription or a letter from your doctor stating that you are being treated with the product. You will need to declare the product on your passenger arrival card and carry the product in its original container. You can bring in no more than a 3-month supply of a CBD product or a 1-month supply of any other medicinal cannabis product.
Departing New Zealand
Before you travel overseas, you must check how medicinal cannabis products are classified in any places they plan to visit or transit through. In some countries, possession of cannabis (even with a prescription) is a criminal offence with no exemption for medicinal cannabis products.