Abstracts

Rationale:
The Japan Cannabis Control Law of 1948 prohibited the use of cannabis-derived pharmaceuticals, but the enactment of the Japan Cannabis Control Law Amendment Bill in December 2023 opened the way for their use. The enforcement of this act will partly take place sometime by Dec 13, 2024, to enable the cannabis-derived prescription medicine containing THC as narcotics. In Japan, clinical trials for this medicine is currently underway for three intractable epilepsy disorders (DS, L-G and TSC). On the other hand, cannabinoid products that can be classified as food have been available in Japan since around 2013. We have reported a case of seizure suppression in patients with intractable epilepsy with these products (PMID: 32695984). Among bunch of formulas available over the counter of dispensers, some of this cannabinoids products, classified as food, contains the controlled substance, and its use was banned under the Pharmaceutical Affairs Law, effective as of September 2023. However, we found group of patients with intractable epilepsy that could only obtain seizure control by the products containing the controlled substance. A third track was established to use these CBD products with controlled substances to legally allow their use by an individual report to acquire permission from the government. Since it was anticipated that the physician in charge would refuse to prepare a medical certificate for this user’s self-application to the government, an individual review committee was established to provide expert opinions in lieu of medical certificate from the doctors on charge.




Methods: A Cannabinoid Appropriate Use Judging Committee was established within the Japanese Clinical Association of Cannabimoids, Inc. The members consisted of 8 internal members and 7 external members of the society and the secretariat. The committee made decisions on those who wished to make individual applications.


Results:
By April 2024, 10 cases were reviewed, and 9 cases were judged as appropriate use, and 1 case was judged as inappropriate because seizures were suppressed by a product that did not contain the designated drug. The patient submitted the committee's decision as a supplementary opinion when submitting an individual use application.A representative case will be presented.




Conclusions:
Our goal is to expand the indications for cannabinoid medicines on a prescription basis, narcotics or regular prescription drugs to include intractable epilepsy and other diseases for which efficacy is anticipated, in addition to those three diseases for which clinical trials are being conducted. Patient groups that still need more time before clinical trials must rely on the use of cannabinoid products. It was considered necessary to protect appropriate users while conducting strict pharmaceutical surveillance.




Funding:
This research was supported by the 2024 Japan Health Labor and Welfare Special Research Program "Regulatory Surveillance of Cannabinoid Drugs and Cannabinoid Products 24CA2012 (Principal Investigator: Ichiro Takumi).