(This story has been updated with further analysis.)
New Zealand released highly anticipated proposed medical cannabis regulations Wednesday, representing a “huge milestone” for the country’s burgeoning industry as it looks to become a hub for innovation, cultivation and production, industry sources said.
The government aims to finalize the regulations by Dec. 18, 2019, in order to implement the medical cannabis program in the first quarter of 2020.
Paul Manning, co-founder of Auckland-based Helius Therapeutics, called the proposals “excellent” and said the standards for cultivation and manufacturing are “high, yet workable.”
“These regulations, if implemented, could allow New Zealand to establish itself as a world-class hub for medical cannabis innovation and production in the APAC (Asia-Pacific) region,” he told Marijuana Business Daily.
The document proposes detailed rules to manage:
- Quality standards.
- Licensing of products.
- Distribution of products.
- Prescribing requirements.
- License fees.
- How products will be monitored.
The government is soliciting feedback on the proposals until Aug. 9 to shape the final regulations.
After the consultations are complete, the Ministry of Health will analyze the feedback and work with the Medicinal Cannabis Advisory Group before making recommendations to the government.
The ministry will then seek cabinet approval from the cabinet and work with the Parliamentary Counsel Office to draft the complete Misuse of Drugs (Medicinal Cannabis) Regulations.
One of the most important aspects of the proposed rules would see the establishment of the Medicinal Cannabis Agency.
Some of the agency’s responsibilities will include:
- Licensing of cultivators, manufacturers, suppliers and researchers;
- Controls on advertising;
- Enforcing compliance;
- Sampling and testing for compliance and other requirements, including labeling information; and
- Collecting and assessing information about the products.
The agency will also monitor quality standards and compliance with license conditions.
The draft regulations would allow cultivators to bring illicit cannabis seed to the regulated market, so long as they report the amount to the regulator, along with any other details they have.
Without such a clause, regulated growers would have limited access to legal genetics, according to experts.
“I’m particularly enamored by their illicit-seed amnesty,” said Rhys Cohen, director of Cannabis Consulting Australia.
“This continues to be an unnecessary barrier for Australian companies and will greatly accelerate the development of a (New Zealand) industry.”
The government is seeking feedback on whether “unapproved” medical cannabis products should be prescribed by a medical doctor with the recommendation of a specialist, or only by a specialist, according to the consultation paper.
Either way, industry and patient groups see the involvement of specialists as an unnecessary barrier.
“The requirement for a specialist recommendation to accompany medical cannabis prescriptions was a completely unnecessary addition,” said Manning of Helius Therapeutics.
“This has the potential to significantly inhibit patient access … I expect the regulator to see significant pushback from patients and industry on that point.”
If that requirement remains in the final regulations, Cohen expects it to be amended once the program has been running for a while and people are more comfortable with the new landscape.
More key proposals
Food containing medical cannabis will not be allowed.
The document is proposing two options for a manufacturing quality standard:
- Adopting the current approach for manufacturing in accordance with Good Manufacturing Practice (GMP) for all medical cannabis products.
- Allowing the manufacture of some medical cannabis forms under GMP and others forms under Good Production Practices (similar to Canada’s system).
New Zealand currently does not allow the export of “unapproved” medicine, but the country is proposing to remove that restriction for medical marijuana products that meet quality standards.
That would allow the country’s regulated cannabis businesses to compete against those from neighboring Australia.
Matt Lamers can be reached at email@example.com