New Zealand released highly-anticipated proposed medical cannabis regulations today, representing a “huge milestone” for country’s burgeoning industry as it looks to become a hub for innovation, cultivation and production, industry sources say.
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 region,” he told Marijuana Business Daily.
Parliamentarians approved the Medicinal Cannabis Scheme in early 2018.
The document proposes detailed rules to manage:
Licensing of products
Distribution of products
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 approval from 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;
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 licence 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 see significant push back from patients and industry on that point.”
If that requirement remains in the final regulations, Cohen expects it to be amended once the scheme has been running for a while and people are more comfortable with the broader program.
More key proposals
Food containing medical cannabis will not be allowed.
The document is offering two options for a manufacturing quality standard: The country could adopt the current approach for manufacturing in accordance with Good Manufacturing Practice (GMP) for all medical cannabis products.
The second option the country is considering is to allow for 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.
奥克兰 Helius Therapeutics 联合创始人保罗•曼宁( Paul Manning )称，这些提议“很好”，并表示，种植和制造的标准“高但可行”。
“这些规定如果得到实施，将使新西兰能够成为亚太地区医用大麻创新和生产的世界级中心，”他对《 Marijuana Business Daily 》表示。
澳大利亚坎纳比斯咨询公司( Cannabis Consulting Australia )董事里斯•科恩( Rhys Cohen )表示：“我尤其对他们的非法种子特赦感到着迷。”
Helius Therapeutics 的 Manning 说：“要求专家建议随用医用大麻处方是完全不必要的补充。”“这有可能显著抑制患者的进入……我预计监管机构会在这一点上看到患者和行业的重大倒退。”
该文件提供了两种制造质量标准的选择：国家可以对所有医用大麻产品按照《良好制造规范》（ GMP ）采用目前的制造方法。
该国正在考虑的第二个选择是允许根据 GMP 和其他形式的良好生产规范（类似于加拿大的制度）生产某些医用大麻。