Medical cannabis restricted under outdated narcotics regulations

Rep. Hyungdong Kim has introduced a bill related to the Narcotics Control Act to permit non-psychoactive CBD commercialization and manufacturing

To decrease reliance on imported 'Epidiolex' and to decrease patient burden

Domestic production of a therapeutic that relied entirely on imported products would conserve national health insurance resources

Product photo of Epidiolex

Both the ruling and the opposition parties in South Korea are introducing bills to permit the domestic commercialization and marketing authorization of medical cannabis that offers validated clinical efficacy without psychoactive or addictive risks, such as cannabidiol (CBD). This would increase the likelihood of bypassing long-standing regulatory bottlenecks for treatment access for patients, such as those with epilepsy

If enacted, the legislation will improve South Korea's outdated Narcotics Control Act, which previously failed to distinguish non-psychoactive CBD from psychoactive tetrahydrocannabinol (THC). This regulatory reclassification is anticipated to bring a regulatory shift within the conservative Ministry of Food and Drug Safety (MFDS).

On the 6th, Rep. Hyungdong Kim of the People Power Party submitted a bill that reclassifies medically viable cannabis derivatives as psychotropic substances. By clarifying the definition of cannabis, the amendment enables pharmaceutical companies to apply for domestic manufacturing and marketing authorizations.

Earlier in March, Rep. Mihwa Seo of the Democratic Party of Korea introduced a separate amendment to the Narcotics Control Act with a similar regulatory intent.

Globally, regulatory bodies have increasingly removed CBD-based therapeutics from restricted narcotics schedules, facilitating commercial product development and expanding patient care. In contrast, the South Korean MFDS has restricted access solely to personal-use imports handled via the Korea Orphan & Essential Drug Center (KODC), under the rationale that full commercial legalization could precipitate widespread substance abuse.  

Consequently, patients with intractable epilepsy continue to face severe therapeutic limitations. At present, Epidiolex, an orphan therapeutic indicated for rare pediatric-onset epilepsies, remains the only medical cannabis-derived pharmaceutical authorized for use in South Korea.

Although Epidiolex relies entirely on imports, its reimbursement status has significantly reduced out-of-pocket expenses for patients. However, the remaining premium cost is borne entirely by national health insurance fiscal reserves, impacting state healthcare expenditure.

Ultimately, the current law must be amended before the patent expiration of Epidiolex. Aligning domestic CBD regulations with international standards would enable domestic generic drug manufacturers to initiate bioequivalent CBD generics, thereby conserving national health insurance resources. This strategic commercial and fiscal implication explains why the pharmaceutical sector is closely tracking the legislative proposals introduced by Representatives Kim and Seo.  

Rep. Kim’s proposed bill classifies medically viable cannabis derivatives as psychotropic medicines. It also expands the statutory definition of a cannabis cultivator to allow cultivation intended for supplying raw materials to licensed narcotics manufacturers for pharmaceutical production, moving beyond traditional fiber or seed harvesting constraints, subject to explicit authorization from the Minister of the MFDS.

Rep. Kim’s proposed bill strictly prohibits the handling or distribution of cannabis-derived psychotropics that deviate from supply chain compliance standards mandated by Presidential Decree, establishing stringent penalties for non-compliance. Furthermore, cultivators producing cannabis for pharmaceutical manufacturing are required to report total acreage, operational status, and harvest yields to the MFDS Minister under Prime Ministerial Decrees, with a mandatory clause dictating that any crop volume exceeding predefined supply contracts must be destroyed and formally documented.

Additionally, the bill mandates the creation of a specialized institute, the "Medical Narcotics Raw Material Management Center", to secure active pharmaceutical ingredients (APIs) and oversee safety compliance. This center will monitor designated cultivation zones and manage annual cultivation supply agreements with licensed growers for downstream pharmaceutical formulation.

The legislative objective is to establish a highly regulated, government-controlled supply chain tracking everything from raw crop cultivation through extraction, purification, active ingredient manufacturing, and raw material volume allocation.

An official from the National Assembly's Health and Welfare Committee note, "The swift passage of the Narcotics Control Act amendment, along with supportive government initiatives to localize CBD oil production, would effectively prevent fiscal loss from national health insurance resources while significantly expanding therapeutic options for patients with intractable conditions like epilepsy," and added, "The bill encompasses both the clinical optimization and national health security."

Meanwhile, following the introduction of this bill, Rep. Kim plans to host a policy forum on the 7th at the National Assembly Representatives Office Building to continue discussions under the theme "Strategies for Introducing Cannabis-Derived Pharmaceuticals to Expand Therapeutic Options for Rare·Intractable Disease Patients and Secure Essential Medicine Supply Chains".