FOCUS ON MEDICINAL CANNABIS – South Korea to be the first East Asian Country to Legalise Medicinal Cannabis
In a surprise development this week, the South Korean government passed legislation to permit patient access to medicinal cannabis. Changes to the Korean Narcotics Control Act (“the Act”) will enable patients to access medicinal cannabis in South Korea under prescription from a medical practitioner. While the changes to the Act are quite restrictive, they nevertheless represent the first shift in policy relating to cannabis use, in a region that is widely recognised as enforcing some of the harshest penalties for cannabis use relative to the rest of the world.
Medicinal Cannabis in South Korea
Prior to amending the Act, the import, export, manufacture and sale of “marijuana” was prohibited in South Korea, with the exception of the collection of seeds and fibres from the plant for textile production, research or state-approved use. As the term “marijuana” was broadly defined under the Act as any substance or chemical product derived from Cannabis sativa, including its resin and raw materials, the medical use of cannabis-based therapeutics was considered illegal in South Korea.
Under the changes to the Act, the South Korean government will permit the use of cannabis-based therapeutics that have been approved in other jurisdictions, meaning that cannabis oil, extracts, inflorescence and tinctures that have not been approved in other jurisdictions as therapeutic goods will remain illegal. Accordingly, suitable medicinal cannabis products are likely to be limited to pharmaceutical products, such as Epidiolex, Marinol, Cesamet and Sativex, all of which have previously been approved by drug and therapeutic goods agencies in the UK, France, Germany, Australia and/or the US.
Furthermore, the Ministry of Food and Drug Safety has indicated that it will seek to restrict and prioritise access to medicinal cannabis products to specific patient cohorts, such as those with cancer, HIV/AIDS, epilepsy, seizure disorders and rare diseases.
Patient Access Pathway
Patient access to medicinal cannabis products in South Korea will be subject to a two-stage approval process. In the first stage patients will be required to obtain a prescription and official medical report from a doctor indicating that the patient requires the medication. This requirement is relatively uncontroversial, and is consistent with other jurisdictions, such as Australia, where medicinal cannabis is generally considered to be a treatment of “last-resort” to be prescribed only where standard of care treatments have failed.
Thereafter, the patient will be required to seek an additional approval from the Korean Orphan & Essential Drug Centre (the “Centre”). Following approval, the Centre will then import the approved product for the patient. In this context it is likely that approval from the Centre will be tightly controlled, with corresponding restrictions and safeguards put in place by the Korean Medical Association to ensure that the drugs are not abused.
Despite the relatively restrictive nature of the legislative framework for accessing medicinal cannabis, this move by the South Korean government represents a fundamental shift in the narcotics approach in a major East Asian country. The question remains whether this move will prompt other Asian jurisdictions to reconsider their position on cannabis as a medicinal, rather than as a recreational or narcotic product.
Further developments in the legalisation of medicinal cannabis in other East Asian jurisdictions will be reported as they arise. If, however, you have any questions about commercialisation or intellectual property relating to medicinal cannabis, our experts at DCC and DCCL will be pleased to assist.