Regulations paving the way for quality medicinal cannabis manufacturing have been released today. These provide formal details on how New Zealand's Medicinal Cannabis Scheme will work.
Regulations to enable a Medicinal Cannabis Scheme were passed on the 18 December 2019. A Medicinal Cannabis Agency will be operational from 1 April 2020 to administer the scheme.
The Medicinal Cannabis Scheme is being established to increase access to medicinal cannabis products, through increasing the supply of products by establishing a licencing regime enabling the cultivating of cannabis in New Zealand and the manufacture and supply of medicinal cannabis products made to quality standards. For the Scheme to meet these objectives, it must deliver quality products to patients and be commercially sustainable.
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.
Helius Therapeutics is proud to have been a key contributor to the regulatory consultation process and has shared some of the research data and expert opinions that help to substantiate key decisions – in particular, removing the requirement for 'specialist sign-off' on medicinal cannabis prescriptions.
At the time of publishing, full details of the final Medicinal Cannabis scheme were not available. However, earlier this month the Ministry of Health released their Medicinal Cannabis Impact Assessment which provides analysis on their recommendations which will guide how the scheme works.
The scheme will set out quality standards for products and processes, as well as detailing both licensing and prescribing requirements. A link to the full Medicinal Cannabis Impact Assessment can be found here.
Summary of the analysis
The requirement for specialist signs-off on prescription (proposed in the consultation earlier this year) will be dropped, meaning all GPs will be able to prescribe medicinal cannabis products without additional oversight.
Good Manufacturing Practice (GMP) will be set as the quality standard for all medicinal cannabis products in New Zealand. This means cannabis companies will require GMP-grade manufacturing facilities, such as the one operated by Helius.
Currently 10 licenses to cultivate cannabis for the purpose of medical/scientific research have been issued, including the market-leading Helius site in East Tamaki.
The scheme introduces a single medicinal cannabis license approach. This means that a company's licence will specify activities that can be undertaken. Additional activities can be added as needed, by applying to the agency (MOH) and paying the additional licence fees.
THC is scheduled as a controlled drug. CBD and THC are both listed as prescription medicines. This means that medicinal cannabis products can only be obtained through a prescription.
A medicinal cannabis product or ingredient that is a controlled drug and meets the minimum quality standard based on evidence provided to the Medicinal Cannabis Agency can be named on a Medicinal Cannabis Licence that authorises supply.
All products will be lab tested to ensure there are no contaminants and that products have the specified levels of active ingredients.
The fee for a commercial medicinal cannabis cultivation license is $2,588. A range of other fees apply.
Fees will be the same regardless of cultivation area.
A risk proportionate approach will be taken to security requirements, depending on the activities undertaken. For example, sites growing high THC cultivars will be subject to greater security requirements than a site growing CBD-dominant plants.
A form of amnesty will be included by way of a 'Declaration of Illicit New Zealand Plant or Seed'. The scheme introduces this option for onboarding genetics from illicit growers to preserve locally-established cultivars in the regulated system. The Ministry has proposed allowing up to 20 plant for 50 seeds per declaration. Each declaration will cost $748.
All typical medical cannabis formats will be allowed, including dried products. However, smokable cannabis products, will not be permitted under the scheme (it's unclear at this time how smoking dry products will be avoided). Edibles, such as gummies, will not be permitted.
Unapproved medicinal cannabis products cannot be advertised in New Zealand (note: all locally produced products will be 'unapproved' initially). We expect this will present challenges for patients and prescribers looking to learn about locally-made products and their the availability under the scheme.
The Ministry will have a $650,000 on-going operating budget, not directly linked to licensing activities, which may be used for prescriber and patient education, and management of the scheme.
Medicinal Cannabis Scheme announcement
Minister of Health Dr David Clark says new regulations will allow local cultivation and manufacture of medicinal cannabis products that will potentially help ease the pain of thousands of people.
Today's regulations, which come into effect on 1 April 2020, set out the quality and licensing requirements for manufacturing and distributing medicinal cannabis.
“Many New Zealanders will have watched a loved one struggle with chronic pain, particular near the end of their lives. Medicinal cannabis products can make a real difference to people’s quality of life,” Dr Clark said.
“Over time this Government’s medicinal cannabis scheme will help people ease their suffering by making a wider range of quality medicinal cannabis products available.
“There is huge international interest in the potential of medicinal cannabis. These regulations mean New Zealand companies will be well placed to manufacture for both the local and international market.
“One significant change in the final Medicinal Cannabis Scheme released today will enable greater patient access and shows the Ministry of Health has listened to healthcare professionals,” says Paul Manning, Co-Chief Executive of Helius Therapeutics, the country’s largest medicinal cannabis company.
He says officials are to be congratulated for designing and finalising robust regulations in a consultative way under a tight statutory timeframe, delivering on the public and parliament’s desire for greater access to affordable medicinal cannabis products.
“The many people who have been fighting for years for patients to have access to high quality Kiwi-produced medicinal cannabis products, can take a bow. This finalised scheme will help restore quality of life to thousands of New Zealanders,” says Mr Manning.
Mr Manning says a key change that officials have made to the final scheme since the discussion document was released in July is dropping the proposed specialist sign-off requirement. Instead, general practitioners will have professional discretion to prescribe medicinal cannabis for any condition.
Helius strongly advocated for GPs to prescribe on their own. Their work included commissioning a large Horizon Research survey of over 700 healthcare professionals in August and publicly releasing the results.
The independent survey confirmed healthcare professional’s strong belief that GPs are already specialists in the field of general medicine, know their patients best, and are perfectly capable of prescribing cannabis-based products on their own, just as they do with other prescription medicines.
With the final scheme empowering GPs, considerable complexity and time is removed for patients, and any concerns about capacity and extra pressure on the health sector disappears,” he says.
In addition to products being available through prescription and dispensed through pharmacies, nurse practitioners will be permitted to prescribe approved CBD products?
What’s more, he says, with Good Manufacturing Practice (GMP) certification required for all medicinal cannabis products, practitioners can have the confidence they’re prescribing products that are of a medical grade manufacturing standard.
Mr Manning says New Zealand healthcare professionals will need to upskill ahead of many medicinal cannabis enquiries from the public, with doctor education now key to patient access.
News that significant Government funding will be dedicated to a prescriber education programme is a significant investment which will make a real difference, he believes.
Survey results, again commissioned by Helius, revealed in April that 89% of those qualified to prescribe medicines said they would prescribe medicinal cannabis products for one or more of 20 medical conditions, if they had enough information, with chronic pain the condition they would most prescribe it for.
The co-founder of Helius Therapeutics says other key aspects of the final scheme include cannabis-based products allowed onto the market without clinical trials and exports permitted, creating a significant economic opportunity.
“Regulators have ensured all the right components are in place to create a new competitive export sector, with the global industry estimated to reach $55 billion by 2025. In fact, there’s no reason why New Zealand cannot become a global centre of excellence for medicinal cannabis innovation. That should be the national aim,” he says.
The Minister of Health confirmed today the Medicinal Cannabis Scheme will be operational by the end of March 2020, when a new Medicinal Cannabis Agency will be in place to receive commercial licence applications. Companies like Helius Therapeutics will then apply to effectively convert their existing research and development licence to a commercial one.
“Over the past 15 months, we’ve been busy building a state-of-the-art facility in East Auckland, recruiting a world-class team, and undertaking considerable R&D. With the regulations and timeframes confirmed by the Government, we are ready to move towards production, with delivering for Kiwi patients our first priority.”
Paul Manning says pressure will remain on Ministry of Health officials to expeditiously enable licenced manufacturing and product supply so thousands of patients can access medicinal cannabis products from next year.
“There is already considerable expertise in this area with 20 companies currently licensed to grow cannabis for research purposes and another 238 growing industrial hemp. It’s expected that at least some of these companies will apply for licences for medicinal cannabis,” Dr Clark said.
The first medicinal cannabis licences are expected to be issued by mid-2020.
In other countries locally grown product has taken over two years to come on the market. Locally grown product will however be available sooner than this in New Zealand, partly due to the research underway already in New Zealand under existing licences with companies such as Helius Therapeutics..
There will be a single, overarching medicinal cannabis licence to cover medicinal cannabis activities. This licence will specify activities that can be undertaken. Additional activities can be added as needed, by applying to the Medicinal Cannabis Agency and paying the additional licence fees.
Activities that will be allowed under a medicinal cannabis licence are:
Possession for manufacture
Full details of the licensing regime can be found here.
The regulations include restrictions to control any contamination or adulteration of medicinal cannabis products. The restrictions set in the Medicinal Cannabis Regulations 2019 require that:
Products and ingredients must not be adulterated.
Active ingredients and cannabinoids contained in a medicinal cannabis product must be extracted only from cannabis.
Decontamination treatment of products and ingredients must not adversely affect the quality of the item or use or contain ethylene oxidesmoking is a prohibited form of administration of products.
Sterile dosage forms are prohibitedproducts and ingredients must not have been treated with a pesticide unless the pesticide is a trade name product registered under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 for use on cannabis.
MedCan 2020 timed for launch of new scheme
Further, timed to align with the new scheme going live, New Zealand will have its first international medicinal cannabis summit on 18 and 19 March.
MedCan 2020 will bring together key industry stakeholders to collaborate and learn from local and international thought leaders.
Organised by BioTechNZ, the SkyCity event is supported by the Government, with Helius the foundation sponsor.