South Korea Carefully Unlocks the Door

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Last November, a bill legalizing medicinal cannabis in South Korea quietly passed through the government’s National Assembly, promising patients access to medicines within a few months. Though the bill is conservative and careful, it nonetheless makes South Korea the first country in East Asia to legalize cannabis products.

Some advocates are disappointed at the short list of drugs that will be initially allowed, and also worry about the strictly limited access and the expected high prices for the medicines, which are not covered by insurance in South Korea. But it’s a remarkable turn of events in a nation that has a history of holding a fierce line against anything related to cannabis.

On March 12, the country will begin to import a handful of pre-approved cannabis-based drugs for patients who qualify under conditions set forth by the government. Epidiolex, Sativex, Cesamet, and Marinol are on the current list, which is still undergoing final approval. Each drug is intended to cover a specific ailment. Epidolex will be targeted toward patients suffering from epilepsy; Sativex for those with multiple sclerosis; Cesamet and Marinol to prevent nausea and vomiting for patients undergoing cancer treatments like chemotherapy, with the latter drug also directed toward those experiencing anorexia nervosa resulting from AIDS.

Drugs considered for import will only include those that have been approved by federal agencies abroad, such as the United States’ Food and Drug Administration, according to Im Hyun-jong, the Chief Secretary for Assemblymember Shin Chang-hyun, one of the key politicians who proposed the medicinal cannabis bill last year. “We can not manufacture cannabis-based drugs in Korea, so the four drugs we are trying to bring in are those that have already been approved for efficacy and safety in overseas markets,” Im told Cannabis Wire. The list could change, although the four drugs on the current list will most likely be approved, according to both Secretary Im and the Ministry of Food and Drug Safety.

The procedure for obtaining one of the approved drugs is daunting. On March 12, patients will be able to seek a medical diagnosis (which will look no different than a medical cannabis recommendation in the United States) from a doctor for the cannabis-based drugs, the first step for those seeking approval. They can then send their application, which will include the diagnosis, a letter from the doctor, and medical records, to South Korea’s Ministry of Food and Drug Safety, the key government agency responsible for the specifics of this new legislation, through fax, mail, or online, according to a representative from the Ministry. If the request is approved, the Korean Orphan Drug Center, a public institution that works to facilitate medical access for patients with rare diseases in South Korea, will import the requested drug.

Though it is yet unclear how many patients may try to seek cannabis-based drugs once they can, between 3,000 to 4,000 patients would qualify for Epidiolex, the drug that is expected to garner the most applicants in South Korea, according to a federal survey. “Of that number, we are expecting at least over 1,000 patients to apply for approval for the drug, as they have no alternative domestic treatment possibilities,” said Im.

The current tentative list of approved drugs is short, but it has room for expansion, according to Yoon Ji-sang, a representative from the Ministry of Food and Drug Safety. “If in a different country there is a cannabis-based drug that has been approved that we decide we want to use and need to use domestically,” Yoon said, “then we will begin to approve that process.

“In other words,” he added, “we don’t have a list of drugs that we think is the ultimate finalized list.”

Though most patients understand that there needs to be a modest starting point for medical cannabis in South Korea, a country that has always drawn a hard line against anything cannabis-related, others feel frustrated with the small number of drugs that have been approved, as well as the hurdles required to obtain them.

Doctor Hwang Ju-yeon—who in 2017 was caught by federal prosecutors smuggling cannabis oil into South Korea for her young son, who suffers from epilepsy—remembers the moment she heard that the bill had been passed last November. “I was at the hospital when I heard the news and I remember feeling a little disappointed,” Hwang said. “But I felt the first step was still the biggest step, so I thought to myself as more time passed, maybe things will improve, because what I wanted wasn’t this.”

“I wanted CBD oil to be legalized, rather than Epidiolex, because if CBD oil were to be passed, more patients would be able to afford cannabis-based treatments at a more reasonable cost,” Hwang continued. “Epidiolex is ten times more expensive.” Hwang said the cost for a year’s worth of treatment with Epidiolex would be more than 30,000,000 KRW (around $26,830 USD), starkly limiting the number of children who would be able to access this treatment.

“So I remember thinking to myself, at the time, that it was a bit of a shame,” she said. “But we can’t stop fighting for this at this point.”

After learning that her son had epilepsy, and after attempting unsuccessfully to use treatments that were domestically available to treat him, Hwang turned to cannabis oil as a last resort in early 2017. For months, she ordered it online, until one of her packages was seized by federal prosecutors who asked her to come in for questioning. She was not charged or fined, but from that point on, Hwang says, she decided to be more open about her situation to the press, in order to raise awareness.

Though there are more details to be finalized before March 12, the only official method at the moment for approved patients to receive their medicine is to go directly to the Orphan Drug Center in Seoul to pick up the supply personally, according to the Ministry of Food and Drug Safety. For those who live far from the center, which has only one location in South Korea, this may prove to be a challenge.

Alternative options, such as delivery or pickup by an authorized other individual, are still under discussion. Other details—such as how large a supply a patient can possess at a single time, or how long processing will take before they can receive the drugs after applying—are still under deliberation within the Ministry of Food and Drug Safety. With only a short time  to go until the official start date of the legalization of medicinal cannabis in South Korea, many questions remain.

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