n December 12, 2024, Japan enacted its amended Cannabis Control Law (CCL) and Narcotics and Psychotropic Substances Control Law (NPSCL). The new regulations opened the possibility of cannabis-derived drugs in Japan, especially those containing cannabidiol (CBD).

Situation Necessitating the Amendment

Before this amendment, the CCL prohibited medicinal use of cannabis products: anything derived from the cannabis plant. Scientific research on cannabis products, including clinical trials, was allowed, but there was no possibility of Japan’s Ministry of Health, Labor and Welfare (MHLW) approving any of these products as pharmaceuticals: cannabis itself, its resin and other preparations, or cannabinoids (chemicals contained specially in cannabis).

Some cannabinoids, most notably tetrahydrocannabinol (THC), do have hallucinogenic and dependence-forming pharmacology. But others, including CBD, do not. It did not stand to reason that these different cannabinoids were lumped together and prohibited for medicinal use.

In 1985 (four decades ago), the US FDA approved synthetic THC (dronabinol) as a drug to treat nausea and vomiting caused by cancer chemotherapy. The World Health Organization (WHO) reports that as of 2018, medicinal cannabis (administered through smoking) was legally usable in countries such as Canada, Australia, and many European countries. Although the US has not yet legalized medical cannabis on the federal level, many states have laws allowing use of medicinal cannabis in place.

One drug containing cannabidiol (EPIDIOLEX®) has been in use in the US and EU to treat severe forms of pediatric epilepsy since 2018 and 2019, respectively. But even CBD could not reach Japanese patients because of the prohibitive clause in the CCL.

In response to outcries from patients and doctors, however, a phase 3 trial of this same CBD pediatric epilepsy medication started in Japan in 2022. In a few years from now, the developer will be ready to file an application for marketing approval; MHLW designated this product as an orphan drug in April 2024, in anticipation of the passage of the amendment the following December.

MHLW has also been concerned about the persistently high number of cannabis CCL offenders (about 6,000 a year) (in Japanese only), especially among youth. Before this amendment, the CCL lacked any provision to prohibit self-(ab)use of cannabis, unlike other Japanese drug-control laws, notably the NPSCL. The MHLW deemed this situation unsatisfactory (in Japanese only) and had been awaiting a chance to introduce penalties for self-use to further deter violations of the CCL among young persons.

Interestingly, the MHLW was aware that many advanced countries do not punish self-use of drugs. Nor does the United Nations’ Single Convention on Narcotic Drugs require its parties (countries that ratified the treaty, including Japan) to punish self-use. Even so, the authority upheld the pre-emptive punishment of self-use, despite the global trend of liberating/legalizing cannabis use.

Amended Laws

The amendment removed from the CCL the clauses that prohibited medicinal use of cannabis as well as the unauthorized manufacture, possession, and trading of the drug. Articles that regulate cultivation of cannabis for industrial or research purposes remain in place. The law is renamed Law on Cannabis Cultivation Regulation. Instead, cannabis, its products in various abusable forms, THC and their hallucinogenic isomers (but NOT harmless cannabinoids like CBD), are designated as narcotics and regulated as such under the NPSCL.

CBD-containing pharmaceuticals can now be developed without restrictions from the CCL or NPSCL. Clinical trials of CBD products in addition to the previously mentioned CBD product (approved in the US and EU for pediatric epilepsy) have already started. Cannabis products and THC designated as narcotics can also be developed as narcotic pharmaceuticals, just like morphine and cocaine. Medicinal (smokable) cannabis is now allowed under the law.

Self-(ab)use of newly defined “cannabis products,” which DOES NOT include innocuous cannabinoids such as CBD but DOES include smokable forms of the plant and its resin, is now an offense punishable under the NPSCL with maximum imprisonment for 7 years; under the CCL (before amendment), possession of the drug earned up to 5 years of jail time. Authorities expect that the strengthening of punishment will provide stronger deterrence for cannabis-related offenses.

International Drug Control

This move by the Japanese government also has implications for international drug control. Each country’s regulation of drugs is largely dictated by the Single Convention on Narcotic Drugs, an international treaty that controls the production, supply, trade, and transport of narcotic drugs. The United Nations Commission on Narcotic Drugs (CND), under the Economic and Social Council (ECOSOC), oversees the treaty’s implementation.

Cannabis was listed in Schedule IV of the convention as a substance that is particularly liable to abuse, produces ill effects, and lacks therapeutic value. The convention applies the strictest control measures to the substances in this schedule and generally discourages their use for medical purposes. Heroin is a prime example.

In 2020, the CND voted to follow the WHO recommendation and removed cannabis from the schedule. While the US and major European member states of the commission supported removal, Japan opposed it, stating that scientific evidence for the medical value of cannabis products was not robust enough and that the proposed deregulation might give rise to negative health and social impacts, especially among youth. Japan was not the only opposition, and the final margin was slim; 27 in favor, 25 against, and 1 abstention (out of 53 CND member states).

Cannabis, however, remained on Schedule I of the convention. This means that cannabis joined the group of narcotics, exemplified by morphine and cocaine, that are legally usable for medical purposes with appropriate restrictions, but not for nonmedical or nonscientific purposes.

Though the CCL amendments were largely driven by domestic needs, they aligned Japanese domestic regulations on cannabis to changing international rules at the same time. However, the country’s conservative attitude towards cannabis has been obvious throughout. Innocuous CBD should not have been regulated in the first place, and MHLW duly eliminated it from under the CCL regulation. For MHLW to approve smoking (which is intrinsically harmful) marijuana to release its hallucinogenic or sedative properties as medicine to, for example, alleviate cancerous pain seems to remain a remote possibility.