December 6, 2023 – The revised Cannabis Control Law, allowing the use of pharmaceuticals derived from cannabis, was approved in the plenary session of the House of Councillors. The law is expected to come into effect in the latter half of 2024. Additionally, a new offence for cannabis use was established, enhancing measures against abuse. Previously, possession and transfer of cannabis were subject to penalties, but with the new law, the act of using cannabis is also prohibited, accompanied by punitive measures.
Japanese CBD market in 2024
The amended law redefines the illegal status of “cannabis,” shifting from “structural restrictions” to “ingredient regulations” based on the psychoactive component THC. This change enables domestic production of CBD products that were previously challenging, anticipating industry expansion. According to statements made during parliamentary discussions, CBD companies are now responsible for self-regulation, ensuring through testing that the THC content in their products remains below the defined limits. The THC limit is currently undetermined, but the Pharmaceutical and Food Safety Bureau director suggests it will be set at an extremely low level, drawing inspiration from international standards. In case post-purchase investigations reveal THC levels exceeding the defined limit, sellers are required to promptly recall their products. Buyers are advised to either return the products or consult health authorities. The director notes that non-intentional offenses are generally not prosecuted, but there remains a possibility of violating cannabis control laws. Concerns were expressed during the questioning about research indicating CBD’s potential conversion to THC under heat or acidic conditions. While the pharmaceutical bureau director explained that such conversions do not occur within the human body under normal circumstances, intentional conversions could potentially lead to unauthorized narcotics manufacturing.
Global Issues in Cannabinoid Content
Various countries are grappling with issues related to the cannabinoid content in cannabis products. In the United States, for instance, inspections have revealed discrepancies between the labeled cannabinoid content on CBD products and their actual content. Similarly, Canada faces challenges related to the THC content in products, leading Ontario to announce independent testing procedures. Japan’s regulatory authorities also plan to verify compliance through testing procedures, addressing issues seen internationally.
Medicines Derived from Cannabis
Under current Japanese law, pharmaceuticals manufactured from cannabis can undergo clinical trials, but usage is restricted, preventing their use in medical settings. Unlike many Western countries where drugs containing cannabinoids, such as cannabidiol (CBD), are already approved for treating refractory epilepsy, patients’ groups in Japan have advocated for the establishment of a system allowing domestic use. Trials for Epidiolex, a high-CBD cannabis-derived pharmaceutical, targeting some refractory epilepsy patients, are already underway. The director of the Pharmaceutical and Food Safety Bureau expects pharmaceutical approval for Epidiolex around the latter half of 2024. While acknowledging the lack of a clear definition for medical cannabis, the Director of the Health Policy Bureau, Katsufumi Jo, clarified that only pharmaceuticals extracted from cannabis would be considered for domestic use, emphasizing adherence to the Pharmaceutical and Medical Device Act. He also explained that the use of joints, cannabis cigarettes would not be permitted in Japan.
Cannabis Use Offence
With the revised law, as medicine derived from cannabis is set to be administered as a “medical narcotic,” THC will be regulated under the Cannabis Control Law (chemically synthesized THC is already regulated). This means that cannabis use, previously not considered a crime, will now be subject to penalties. In deliberations, questions were raised about the possibility of mistaken arrests due to passive cannabis smoking (second hand smoking). The pharmaceutical bureau director responded, stating that judgment would be based on objective circumstances, and exposure to secondhand smoke could be differentiated from cannabis use by comparing lower THC-COOH (THC metabolite) concentrations in urine. While most members of the assembly expressed understanding of the importance of drug prevention, opposition to the strict penalties for cannabis was voiced by the Constitutional Democratic Party, the Japanese Communist Party, and Reiwa Shinsengumi.
Representative Michihiro Ishibashi (Constitutional Democratic Party) expressed concerns that creating new crime for cannabis use could hinder young people’s reintegration into society, potentially leading to their further marginalization. Similarly, Representative Mari Takagi (Constitutional Democratic Party) cited a paper published in “The Lancet” in 2010, indicating that the harmfulness of cannabis is lower than that of alcohol and tobacco. She questioned the appropriateness of strict penalties for cannabis. However, the Ministry of Health, Labor, and Welfare stated that the paper had both supportive and opposing opinions and expressed doubts about its credibility. Regarding the method of surveying the lifetime usage rates of drugs, there were questions about whether estimating values from drug concentrations detected in sewage was desirable. In response, the pharmaceutical bureau director explained that anonymous surveys conducted through the questionnaire method in Japan maintained credibility. He also argued that sewage-based surveys were ineffective since even antibacterial agents had low detectable amounts and were considered “ineffective” in Japan.
Reference: ASA Magazine「参院厚労委、大麻法改正法を可決」「大麻法改正法案が参議院にて可決 法案成立」、NHK News「大麻“使用”禁止盛り込む 改正大麻取締法 参院で可決・成立」、The Asahi Shimbun「Japan lifts ban on marijuana meds, but jail for unauthorized use」
