[Exclusive] Ministry of Health and Welfare: "Bio Companies Offering 'Stem Cell Treatment in Japan' May Be Acting Illegally"

First Official Illegality Concerns Raised Over Overseas Cultured Stem Cell Programs
10,000 to 20,000 Patients Travel Abroad Annually for Treatment; Market Estimated at Billions of Won
"Choosing Overseas Culturing Has Become More Advantageous Under the Advanced Regenerative Medicine Act"

The government has determined that the "Japanese Stem Cell Medical Tourism Program" operated in Korea may potentially violate medical law. This is the first time the government has officially raised the possibility of illegality regarding stem cell treatment programs in which cell culturing and procedures are conducted overseas, drawing public attention. However, whether each individual program is illegal may depend on specific facts, and given the clear limitations of the current medical law, there are calls to promptly initiate discussions on the entire regulatory framework.

According to government and political sources on March 9, the Ministry of Health and Welfare recently replied to an inquiry from Assemblyman Kim Yoon of the Democratic Party of Korea, who is a member of the National Assembly Health and Welfare Committee, regarding "the act of inducing the collection of adipose cells at domestic medical institutions while operating overseas stem cell treatment programs and securing patients' stem cells." The Ministry stated that even if the stem cell injection is performed overseas, introducing or referring patients to a specific medical institution, or engaging in solicitation or brokerage where money is exchanged or a certain percentage of the medical fees is taken as a commission, may constitute a violation of the Medical Service Act. However, the Ministry added that whether a particular program is illegal should be determined based on specific facts.

B, a related company of A, a domestic stem cell specialist corporation, has been operating a stem cell treatment product under the name "Special Anti-cancer and Regeneration Project." The process involves collecting blood and adipose tissue at a partner hospital in Korea, then culturing the cells at a hospital in Japan and administering them to the patient. The cells administered to patients include "anti-cancer immune cells" and stem cells that Company B claims to have developed in-house, with the cost for six treatments amounting to 45.1 million won. During offline consultations, it has been reported that the program was promoted as "recruiting patients for participation in stem cell clinical trials." Assemblyman Kim argues that, as the prevalence and market size of overseas stem cell treatment programs such as these are rapidly increasing, the government must urgently review and address the issue.

Overseas stem cell treatment programs operate by collecting adipose cells in Korea and administering them at medical institutions in countries such as Japan or Taiwan. The cost per session ranges from several million won to as much as 10 million won. According to the 2023 audit by the Ministry of Health and Welfare, it is estimated that between 10,000 and 20,000 patients travel abroad annually for stem cell treatment.

The Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act, Meant to Prevent Capital Outflow from Stem Cell Medical Tourism, Has Instead Created Regulatory Gaps

The issue is that overseas stem cell medical tourism carries the potential for various side effects and regulatory violations, including patient safety concerns. In the past, there have been cases where unauthorized stem cell treatment programs in Korea led to criminal prosecution. In 2015, the Seoul High Court ruled that the act of culturing a patient's cells and supplying them to hospitals for procedures constituted the manufacture and sale of "cell therapy products" under the Pharmaceutical Affairs Act, and found the act to be a violation of the law for being conducted without approval from the Ministry of Food and Drug Safety. The government also introduced the "Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biological Products" (commonly known as the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act) to manage these side effects and prevent capital outflow from medical tourism. Under this law, stem cell treatments are allowed within the system through clinical research and procedures, while a management mechanism is established via review and long-term follow-up.

However, there are criticisms that this law, which was introduced for such purposes, has paradoxically created new regulatory gaps. The current legal framework is designed around regenerative medicine practices conducted in Korea, so it does not affect so-called "medical tourism" where the core processes are carried out abroad. In the past, culturing and administering stem cells in Korea would result in prosecution under the Pharmaceutical Affairs Act, but when culturing and procedures are performed at overseas medical institutions, direct application of Korean law becomes difficult.

This limitation is also evident in the Ministry of Health and Welfare's interpretation. The Ministry views the exchange of money during the process of introducing or referring patients to specific medical institutions as potentially violating the Medical Service Act, but has clarified that core medical activities such as stem cell culturing or administration themselves are not subject to domestic medical law. As a result, even if patients are recruited and cells are collected domestically, when culturing and procedures are performed overseas, the core processes directly related to patient safety fall into a regulatory blind spot in Korea.

"A Management System for Overseas Stem Cell Treatments Is Urgently Needed... Patients Bear the Burden of Assessing Efficacy"

Experts point out that the current system effectively neglects overseas regenerative medicine. Kim Eun-jung, a legislative researcher at the National Assembly Research Service, stated, "The current legal system is designed based on domestic regenerative medicine, so there is no separate management framework for regenerative medicine performed abroad. This sends a signal to businesses that choosing overseas culturing is more advantageous from a regulatory perspective than satisfying strict domestic requirements."

The Ministry of Health and Welfare explained, "Cells themselves, as opposed to pharmaceuticals, are treated as regular cargo, and there appears to be no separate health or medical law that specifically regulates them." Furthermore, while the culturing process may fall under pharmaceutical manufacturing or regenerative medicine, since it is conducted in Japan, it is subject to Japanese law and not domestic law. Although patients are recruited and cells are collected in Korea, the most high-risk processes of culturing and administration remain in a legal vacuum, outside the oversight of any government agency.

Researcher Kim emphasized, "The risk factors—such as the safety verification of cultured stem cells, the potential for exaggerated medical claims, and the high-cost treatment structure—are fundamentally unchanged from past incidents. With overseas stem cell treatment programs for domestic patients on the rise, it is necessary to establish at least a minimal management system covering the entire process, including the export of human cells and their overseas culturing and administration."

Ultimately, the responsibility for judging the efficacy and safety of these treatments is in effect shifted to individual patients. Experts especially warn against exaggerated claims about the benefits of stem cell therapy. Cha Hyukjin, chair of the academic committee of the Korean Society for Stem Cell Research, stressed, "When companies or medical institutions merely use the term 'stem cell,' it is often perceived as if it has vast therapeutic potential, but in reality, only limited functions of specific cell groups have been confirmed. Effects such as anti-cancer or anti-aging have not been scientifically proven."

This content was produced with the assistance of AI translation services.