New Zealand unveils proposed medical cannabis regulations; aims for 2020 launch

新西兰颁布医用大麻法规草案,计划打造亚太地区医用大麻生产创新中心

2019-07-11 15:03:00 mjbizdaily

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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: 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 approval from cabinet and work with the Parliamentary Counsel Office to draft the complete Misuse of Drugs (Medicinal Cannabis) Regulations. New agency  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 licence conditions. Seeds 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.” ‘Inhibit access’ 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.
行业消息人士称,新西兰今日发布了备受期待的拟议中的医用大麻法规,这标志着该国新兴行业的一个“巨大里程碑”,该国有望成为创新、种植和生产的中心。 政府计划在2019年12月18日前完成法规的定稿,以便在2020年第一季度实施医用大麻计划。 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。 2018年初,国会议员批准了药物大麻计划。 该文件提出了管理的详细规则: 质量标准 许可的产品 分配的产品 处方的要求 许可费用 如何监控产品 政府正在征求有关建议的反馈,直到8月9日,以形成最终法规。 磋商完成后,卫生部将分析反馈意见,并与坎纳比斯咨询小组合作,然后向政府提出建议。 然后,卫生部将寻求内阁批准,并与议会法律顾问办公室合作起草《药物滥用(药用大麻)条例》。 新机构 拟议规则的最重要方面之一是设立药用大麻管理局。 该机构的一些职责包括: 种植者、制造商、供应商和研究人员的许可证 控制广告 执行合规 对符合性和其他要求进行抽样和测试,包括标签信息 收集和评估产品信息 该机构还将监测质量标准和许可证条件的遵守情况。 种子 该条例草案将允许栽培家将非法大麻种子带到受监管的市场,只要他们向监管机构报告数量以及他们拥有的任何其他细节。 专家们表示,如果没有这样的条款,受监管的种植者获得合法基因的机会将有限。 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。” “对澳大利亚企业来说,这仍然是一个不必要的障碍,将大大加快(新西兰)产业的发展。” “禁止访问” 根据这份咨询文件,政府正在寻求有关“未经批准的”医用大麻产品是否应由医生根据专家的建议开出,还是只由专家开出的反馈意见。 不管怎么说,行业和患者团体都认为专家的参与是不必要的障碍。 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。” 如果这一要求仍在最终法规中,科恩预计,一旦该计划运行了一段时间,人们会对更广泛的计划感到满意,就会对其进行修改。 更多重要建议 不允许含有医用大麻的食物。 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。 新西兰目前不允许出口“未经批准”的药品,但该国提议取消对符合质量标准的医用大麻产品的限制。 这将使该国受监管的大麻企业能够与邻国澳大利亚的企业竞争。

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