Regulations pave way for quality medicinal cannabis manufacturing
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.
“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. It’s expected locally grown product could be available sooner than this in New Zealand, partly due to the research underway already in New Zealand under existing licences.
“People with prescriptions for medicinal cannabis products can currently fill prescriptions with products sourced from overseas, which are often costly,” Dr Clark said.
“I’m confident increased competition from local manufacturers will drive prices down over time.
“However, sadly we know some people won’t be able to wait for domestic manufacturers to begin production.
“So as a compassionate measure, people eligible to receive palliation will continue to be exempt from prosecution for illicit cannabis. That will be reviewed once the Scheme has been in operation and more quality products become available.
"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,” Dr Clark said.
NOTE: The regulations are available here: health.govt.nz/MedicinalCannabisScheme
The Medicinal Cannabis Scheme will enable domestic cultivation and manufacture of medicinal cannabis. The Scheme will include a licencing regime for cultivation of cannabis for medicinal use, and the manufacture and supply of medicinal cannabis products.
A medicinal cannabis agency, within the Ministry of Health, is being established to oversee the Scheme. The Agency will provide guidance on the Scheme for health practitioners, industry, and consumers.
The Scheme includes appropriate restrictions to ensure cannabis is grown under appropriate security, and batch testing of products to limit contamination, test shelf life, and accurately identify the level of active ingredients.
As for all unapproved medicines, advertising of medicinal cannabis products isn’t permitted and a cost recovery scheme will be in place to cover the costs of administering the licensing and regulatory side of the scheme.
There has been a significant level of consultation and advice sought from those already interested in the scheme and as a result there has already been a significant reduction in the licensing costs to those initially proposed by the Ministry of Health.
The medicinal cannabis products permitted under the scheme include dried products, a variety of tablets and liquids but do not allow products able to be smoked.
All medicinal cannabis products need to be prescribed by a medical practitioner and obtained directly from the medical practitioner or from a pharmacy.
The standards will apply to both imported and locally produced products and will allow people to be confident they’re receiving quality products.