The Ministry of Health has published the proposed regulations and standards for medicinal cannabis, from cultivation to quality standards. Public consultation is open for four weeks. Here's everything you need to know.
“Making medicinal cannabis more readily available has the potential to help ease the suffering of thousands of people who are living in pain, so it’s important we get these regulations right,” Dr Clark says.
“The legislation Parliament passed in December paved the way for greater access to medicinal cannabis products and ultimately will allow New Zealand companies to manufacture quality medicinal cannabis products for local and international markets.
“This is another example of the progress the Coalition Government is making on enhancing the wellbeing of New Zealanders, while also boosting business opportunities.
“We’re now looking for feedback on whether the proposals in the consultation document meet our overall goal of improving patient access to quality medicinal cannabis products.
“I encourage the health sector, industry and the public to engage so the final regulations can be shaped by a wide range of perspectives,” says Dr Clark.
“We are also looking for views on how these products are prescribed, the quality standards for medicinal cannabis products, licensing for cultivators and manufacturers, barriers to patients accessing these medicines and several other proposals.
The regulations supporting the Medicinal Cannabis Scheme will be finalised by 18 December 2019 and the Ministry of Health anticipate having the Medicinal Cannabis Scheme operational in the first quarter of 2020.
“New Zealanders fought hard to achieve strong parliamentary support for medicinal cannabis last year. Now it’s really important people have their say on the design of the regulations,” says Paul Manning, Executive Director of Helius Therapeutics, the country’s largest medicinal cannabis firm.
“Helius strongly believes every New Zealander has a natural right to a pain-free existence. Primarily the regulations need to ensure patient, safety, access, and affordability. I’m pleased to see these key outcomes are also driving the discussion document,” says Mr Manning.
The consultation proposal was informed by feedback from a medical cannabis advisory group that includes medical professionals and consumer and industry representatives. This group will continue to provide feedback as the medicinal cannabis scheme is developed.
The Ministry of Health has opened public consultation on the proposals for the medicinal cannabis regulations needed to support the Medicinal Cannabis Scheme. Consultation closes Wednesday 7 August 2018 at 5 pm.
The Government has committed to establishing a Medicinal Cannabis Scheme to improve access to quality medicinal cannabis products. The Scheme will do this through:
Enabling the commercial cultivation of medicinal cannabis and the manufacture of medicinal cannabis products in New Zealand
Setting standards for medicinal cannabis products so that medical practitioners can prescribe them with more confidence.
A regulatory system, with controls on the cultivation of cannabis and the manufacture and supply of medicinal cannabis products, is needed to support the Scheme. The regulations are being developed to establish the regulatory system.
Opinion: What's great about the regulations?
We think the Ministry of Health has put forward the basis of an excellent medicinal cannabis scheme for New Zealand. We are thrilled to see high yet workable standards for cultivation and manufacturing.
The proposal will allow access to cannabis cultivars that have been established and bred here in New Zealand through an amnesty-style process, which could uncover genetics that have adapted to our environment in unique ways. It also sets up a clear licensing regime that will attract quality, professional operators across the supply chain.
All in all, we think the Ministry of Health has done a great job. We think these regulations, if implemented, could allow New Zealand to establish itself a world-class hub for medical cannabis innovation and production in the APAC region.
Opinion: What's wrong with the regulations?
In our view, there is one major flaw in the proposed regulations and it needs to be addressed. Regulators have stated that, for patients to access medical cannabis products, a specialist recommendation will be required in addition to a GP's approval.
For example, this means that a patient suffering with chronic pain would need to get a recommendation from a pain specialist – of which there are only a few in the country – before their GP can prescribe them a cannabis-based product. In other words, a patient will need approval from not one but two doctors in order to access a cannabis product.
We think this is a unnecessary addition. This requirement has the potential to significantly inhibit patient access. GP’s are more than qualified to prescribe these products on their own. The regulator will likely see significant push back from patients and industry on this point. We strongly encourage our fellow New Zealanders to submit their views on this matter through the consultation process.
How to have your say
The closing date for submissions is 5.00 pm, Wednesday 7 August 2019.
We suggest you start by reading the Short Guide to the Consultation Document (coming soon), which highlights the areas of interest for different audiences. Then read the sections of the Medicinal Cannabis Scheme Public Consultation Document relevant to your interests.
You can download a copy here:
Word version: Medicinal Cannabis Scheme consultation (Word, 715 KB)
PDF version: Medicinal Cannabis Scheme consultation (PDF, 1.2 MB)
You can then provide feedback by:
Using the Ministry of Health's online tool. This is their preferred way to get feedback. Alternatively you can send an electronic submission to firstname.lastname@example.org using the downloadable submission form (Word, 483 KB).
Your feedback will be very important because it will help shape the final proposals, ensuring they are workable and that the purpose of the legislation is achieved. Helius encourages all stakeholders to get involved and make a submission, particularly patients, healthcare professionals and our fellow industry members.
Ministry of Health are also holding information sessions in Auckland, Wellington and Christchurch and will be providing additional material for those who can’t attend.
For healthcare professionals, a presentation and Q&A on the Medicinal Cannabis Scheme will be provided by the Ministry of Health for attendees of our RNZCGP-endorsed Masterclass in Medical Cannabis events, to be held later this month.
If you have any questions, or want more information on the information sessions, please email us at email@example.com.
Next steps after the consultation
The Ministry of Health will analyse the feedback and consult with its advisory group before providing advice to the Government on the outcomes of the consultation, including any proposed changes. The Ministry will then seek approval from Cabinet on the regulatory proposals and work with the Parliamentary Counsel Office to draft the proposed Misuse of Drugs (Medicinal Cannabis) Regulations.
Government are aiming to have the regulations completed by 18 December 2019 and to have the Medicinal Cannabis Scheme operational in the first quarter of 2020.