{"id":4533,"date":"2023-11-06T14:47:44","date_gmt":"2023-11-06T06:47:44","guid":{"rendered":"https:\/\/regask.com\/?p=4533"},"modified":"2024-11-22T04:40:22","modified_gmt":"2024-11-21T20:40:22","slug":"%e5%a4%a7%e9%ba%bb-%e5%a4%a7%e9%ba%bb%e7%b4%a0-%e6%b3%95%e8%a7%84","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/cannabis-cannabinoids-regulations\/","title":{"rendered":"\u5927\u9ebb\u548c\u5927\u9ebb\u7d20\u7684\u76d1\u7ba1\u5f62\u52bf"},"content":{"rendered":"

Article and case study written in collaboration with Life Sciences Law<\/a> – Legal experts in life science industry laws and regulations; providing practical solutions to business challenges and objectives.<\/em> LS Law provides confidence to businesses that the legal landscape is known, risk has been identified and mitigated in a proportionate manner which supports the attainment of its goals and priorities.<\/em><\/p>\n

In 2013, Dr. Sanjay Gupta of CNN presented a program called \u2018Weed\u2019 (*1), in which he profiled a young girl with Dravet syndrome whose life was turned around and significantly improved after being given a CBD-rich hemp extract. This documentary catapulted a fringe product into the mainstream, and within 10 years, surveys suggest that 60% of US adults (*2) and 15% of consumers across Europe (*3) have tried CBD.<\/p>\n

Meanwhile, the regulatory status of cannabidiol (CBD) and cannabis-containing products is playing catch up with consumer demand. Many regulatory agencies across the globe are looking into how to develop a legislative framework fit for purpose.\u00a0 The current routes to market vary widely and are highly complex. Understanding the relevant national and regional status of cannabis products is critical for any company wishing to enter this sector, including manufacturers, distributors, and life sciences companies.<\/p>\n

In this article, we will explain the key terms, cover the main routes to market, and provide insights into a case study we undertook for a client of RegASK who wished to understand the regulatory landscape of Medical Use Cannabis worldwide.<\/p>\n

What is Cannabis?<\/h2>\n

UN Single Convention of Narcotic Drugs<\/h4>\n

\u2018Cannabis\u2019 is defined as the \u201cflowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated,\u201d as per Article 1, Definitions, UN Single Convention on Narcotic Drugs, 1961 (*4). While \u2018\u2019cannabis resin\u2019\u2019 is defined as \u2018\u2019the separated resin, whether crude or purified, obtained from the cannabis plant\u2019\u2019. The Single Convention on Narcotic Drugs (SCND) is an international treaty that controls activities (cultivation, production, supply, trade, and transport) of specific narcotic drugs and lays down a system of regulations (licenses, measures for treatment, research, etc).\u00a0 As of 2022, the SCND has been ratified by 186 countries.\u00a0 It is the primary treaty and document from which all signatory countries refer when they translate the content of the SCND into their national Misuse of Drugs Acts and Regulations.<\/p>\n

At the adoption of the Convention in 1961, cannabis and cannabis resin were listed in both Schedule I and Schedule IV.\u00a0 Schedule IV is the most tightly restricted category, reserved for drugs that are \u2018\u2019particularly liable for abuse and to produce ill effects\u2019\u2019 and whose \u2018\u2019liability is not offset by substantial therapeutic advantages.\u2019\u2019 Its initial placement into this category was not based on science, and a scientific assessment had not been undertaken until 2018 when the World Health Organisation (WHO) tasked the Expert Committee on Drug Dependence (ECDD) to prepare a scientific evidence-based assessment of substances. (5*)<\/p>\n

The ECDD made several recommendations but only one recommendation was adopted.\u00a0 That is to remove cannabis and cannabis resin from Schedule IV and only list it in Schedule I. Schedule I is less restrictive and lists other drugs for medical and scientific purposes such as natural, semi- and synthetic opiates. Schedule I lists a requirement of a medical prescription for the supply or dispensation of drugs to individuals. Since 2021, cannabis and cannabis resin remain listed in Schedule I of the SCND, alongside extracts and tinctures of cannabis. The reason why the cannabis flowers and tops, rather than a single constituent, was originally declared a narcotic is that the structure of the main psychoactive phytocannabinoid, tetrahydrocannabinol (THC) that causes the \u2018high\u2019, was not yet discovered. THC was not determined until three years later (1964) in Israel by Mechoulam (6*).<\/p>\n

The WHO also tasked the ECDD to review the compound cannabidiol (CBD). CBD is one of the main cannabinoids naturally abundant in the plant.\u00a0 In December 2018, the ECDD recommended that preparations considered pure CBD not be placed under international drug control as the substance was not found to have psychoactive properties and presents no potential for abuse or dependence. (7*). The ECDD recommendation 5.5 has been rejected meaning that the UN will not add a footnote to read \u2018preparation containing predominantly CBD and not more than 0.2% of THC are not under international control\u2019 in the vote in December 2, 2020.\u00a0 Despite the recommendation, CBD was not removed from international control. This means that the SCND considers that all cannabis tinctures and extracts made from the flowers of any plant of the species cannabis is subject to schedule I controls, but the change in legal status could facilitate access and availability of medical cannabis.<\/p>\n

National Legislations<\/h4>\n

The UNSC is the primary treaty, and the National Drug Acts and Regulations could be likened to second tier legislation interpreting the UNSC and translating it into their national laws. The interpretation varies widely which makes cannabis such a complex legal topic.\u00a0 There is no harmonised approach, and every country has a unique programme with specific requirements placed on manufacturers, distributors and how patients can access medicinal cannabis.<\/p>\n

Terms to Know<\/h4>\n

The terminology of cannabis and its constituents can be confusing. For clarity we apply the following meaning:<\/p>\n