This week Manatū Hauora – Ministry of Health announced it has received approval to make changes to the Misuse of Drugs (Medicinal Cannabis) Regulations 2019 which they say will better support economic and research opportunities for the medicinal cannabis industry sector and, in turn, benefit Kiwi patients.
"There needs to be changes because the local industry is not yet thriving as expected and ninety per cent of patients are still outside the legal scheme and accessing illicit medicinal cannabis," said Zeacann co-founder and CEO, Chris Fowlie.
Chris James, Deputy Director-General Regulatory Services at Manatū Hauora said the revisions would contribute to a sustainable medicinal cannabis industry: “Supporting a local industry that produces locally grown and manufactured products for domestic and export purposes benefits both industry and those patients for whom it is prescribed.”
The official statement is scant on details, but Zeacann's Chris Fowlie said it looks like the changes, first proposed to industry last December, will make local production much more viable – especially for export.
"With better access to large overseas markets the resulting economies of scale are expected to lead to reduced prices for local patients. "
Mr Fowlie said importing a wider range of ingredients and products should also become cheaper with reduced compliance costs, which will benefit patients.
The changes include allowing:
Exporting cannabis seed;
Exporting cannabis ‘starting material’ (bulk biomass) without having to meet NZ’s quality standard;
Exporting cannabis ingredients and products without having to meet NZ’s quality standard if they are GMP and meet the receiving country’s standard;
Additional ‘forms’ of cannabis (eg tissue culture)
A wider range of products qualifying for approval here, with updated pesticide requirements, the alignment of overseas technical specifications, inclusion of the US pharmacopeia and less duplication of tests.
"I really hope these changes will lead to would-be growers dusting off their plans and having another look at whether they can now give it a go," said Mr Fowlie after reviewing the announcement from regulators.
"Like me they may have shelved plans, but these changes may have a large impact on the viability of growing here both for export and the domestic market. Production costs may be lower, export opportunities now possible, and importing products now more viable."
"For example, Zeacann can now import cheaper ingredients and products that we could not under the current rules, and we will be able to export seeds and bulk plant material to various overseas markets which have made enquiries with us."
However, the Zeacann CEO - the holder of New Zealand's first medicinal cannabis cultivation licence, the first to transfer illicit genetics into legal status, and also a patient receiving legally prescribed cannabis - cautioned that while the proposed changes are all positive, they are rather narrowly focused on product approvals.
The Ministry stressed the changes will not enable the recreational use of cannabis or allow patients to grow their own.
But Mr Fowlie says there are other areas for improvement which could significantly benefit patients, such as shifting low-dose or hemp-derived CBD to over-the-counter (like in Europe and North America), allowing pharmacy compounding of small batches of cannabis meds (like pharmacists can do for any other medicine), and allowing batch-tested craft cannabis production (like in Canada and US states).
"I also wanted to see changes to the de facto ban on marketing which inhibits competition and restricts the information patients need to make informed choices and get the best prices," said the Zeacann CEO and co-founder of AUT's post-graduate course, Introduction to the Science of Medicinal Cannabis. "No sign of that."
But in a positive sign, there are no changes proposed to the prescription and dispensing process.
"New Zealand's medicinal cannabis prescription process is already among the best in the world," said Mr Fowlie. "Although it is frustrating that the ban on advertising means most people don’t know how easy it is or that the prices have already come down a lot."
Zeacann has already made a submission on the proposed changes. Following a public consultation on any material that will be incorporated by reference (such as pharmacopoeias) into the new regulations, we should know more details about the confirmed changes this side of the election.
The new regulations are expected to take effect by the end of the year.