New Zealanders seeking medicinal cannabis may soon get some relief. The Ministry of Health’s new Medicinal Cannabis Agency will open the application process for prospective cannabis cultivators and manufacturers as planned today, even in the midst of the COVID-19 pandemic.
New Zealand’s Medicinal Cannabis Scheme was hard won, said Mark Lucas, CEO of CannaSouth, which holds a cannabis research license in the country and plans to obtain the necessary licenses to supply products to pharmacies. “It’s taken a lot of public pressure,” he said. “What’s driven most of these changes is the public demanding access to these medicines.”
For some, however, the changes are still too late. “Patients are expecting April 1, it’s gonna be all sunshine and rainbows, but really it’s going to be another six months plus,” said Shane Le Brun, founder of Medical Cannabis Awareness New Zealand, an awareness group for patients and prescribers, and a board member for the New Zealand Medical Cannabis Council (NZMCC), an industry trade association. Le Brun cited a Labour Party election campaign promise in 2017 to legalize medicinal cannabis in 100 days. “It’ll be over 1,000 days before we actually have locally made medical cannabis available.”
In December 2018, the New Zealand Misuse of Drugs (Medicinal Cannabis) Amendment Act came into effect, which gave patients requiring “palliation,” often terminally ill people, a defense against cannabis possession and use charges. The government also committed to passing regulations for the Medicinal Cannabis Scheme by December of 2019—which they did—that would take effect on April 1.
Medsafe is the New Zealand authority, within the Ministry of Health, responsible for regulating medicines. Before April 1, Sativex, a medicine made of THC and CBD extracted from cannabis plants, used primarily in patients with multiple sclerosis, was the only Medsafe-approved cannabis product in New Zealand, and only for multiple sclerosis. Other products were considered “unapproved,” and therefore subject to stricter scrutiny and a case-by-case approval.
The new rules include quality standards for medicinal cannabis (both cultivated in New Zealand and imported) and a licensing framework. Doctors can also now more freely prescribe medicinal cannabis products that have met the Ministry of Health quality standards, without a specialist visit.
The kinds of products patients can use will be strictly limited, however, to “dose form” products like oils, tablets, ointments, and creams. Edibles won’t be allowed. The scheme allows for dried flower, but not for smoking: A ministry notice on the Misuse of Drugs Act will allow the “importation and sale of vaporisers approved as medical devices by overseas regulators.”
Meeting the minimum quality standards to cultivate or manufacture medicinal cannabis is no easy feat, either. All products listed on a license must meet Good Manufacturing Practices (GMP) standards, which require extensive documentation and quality control measures.
Lucas said it isn’t easy to build a pharmaceutical-quality operation. “It’s easy to say that. It’s a lot harder to do,” he said. “There’s a massive amount of work to get in a position where you’re going to be able to produce medicines that make the New Zealand quality standards.”
A cultivator who obtains the overarching medicinal cannabis license would pay $8,396 New Zealand dollars ($5,008 USD). Those looking to also manufacture and supply cannabis would need to pay additional fees, bringing their total to around NZ$12,421 ($7,409 USD).
New Zealand’s Medicinal Cannabis Agency sent out an email update on the state of the regulatory rollout on March 31 that assured applicants that their submissions would still be reviewed during the COVID-19 lockdown, and that guidance materials would still be made available on their website—with delays.
“We are doing our best to make the documents available as soon as we can, but the Ministry staff involved are working under extraordinary circumstances,” the agency wrote. “We will let you know as soon as the forms and guidance become available.”
