[비즈한국] It is estimated that 10,000 to 20,000 patients head overseas every year to receive advanced regenerative medicine treatments, such as stem cell therapy. If you add up the non-reimbursable treatment costs and stay expenses, it amounts to about 10 million won per person, meaning approximately 200 billion won is drained overseas annually. This is because, in Korea, advanced regenerative medicine is permitted only for research purposes, not for treatment.
With the implementation of the amendment to the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Advanced Regenerative Medicine Act) last February, there were expectations that a path would open for patients to receive advanced regenerative medicine treatments legally in Korea instead of traveling abroad for care. This is because, albeit with limitations, it became possible to use advanced regenerative medicine and biopharmaceuticals currently under clinical research and development for the treatment of patients with serious, rare, or intractable diseases.
However, even after the amendment took effect, the number of treatment plans approved by the Review Committee for Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Review Committee) and the Minister of Health and Welfare was zero. It was only in September that the Review Committee reviewed the first two applications for treatment plans, but both were rejected on the grounds that there was no evidence to verify the effectiveness of the treatments.
Medical institutions complain that it is not easy to get approval for advanced regenerative medicine treatment plans under the current system. Article 12-2, Paragraph 2 of the Advanced Regenerative Medicine Act stipulates that such treatment can only be performed if clinical research on the advanced regenerative medicine has been completed in advance. This means that results from clinical trials conducted and approved by domestic or international regulatory agencies under the Pharmaceutical Affairs Act cannot be utilized. In effect, it is inevitable that additional time and costs must be invested to receive approval for, and obtain the results from, new clinical research for advanced regenerative medicine.
Because of this, the regenerative medicine industry is calling for adjustments to the risk levels of advanced regenerative medicine to expand treatment opportunities. For "low-risk" treatments, where the impact on human life and health is well-understood and the risk is minimal, treatment plans can be submitted to the Review Committee and performed without separate clinical research. However, it is difficult to find areas categorized as low-risk among the serious, rare, and intractable diseases that became eligible for treatment through the amendment. Most require "medium-risk" treatments that demand significant caution due to potential negative impacts on life and health, or "high-risk" treatments where the impact on life and health is uncertain or carries high risk. Critics point out that even culturing and multiplying a patient's own cells to re-inject them is classified as medium-risk, thereby restricting access to treatment opportunities.
Kwon Ju-ha, CEO of Medvia, a consulting firm specializing in clinical trials and licensing for advanced biopharmaceuticals, spoke at the 'International Forum on Advanced Regenerative Medicine Development Strategies' held during 'Korea Life Science Week 2025' on September 30. He emphasized, "The risk level of advanced regenerative medicine could be adjusted once sufficient research data, safety records, and treatment cases have been accumulated. While lowering it from high to medium is not easy, transitioning from medium to low risk—as in the case of Japan—would allow for treatment to proceed immediately without further clinical trials."
The Alliance for Regenerative Medicine (CARM), consisting of companies and medical institutions aimed at creating an industrial ecosystem for the domestic regenerative medicine sector, has been communicating with the Ministry of Health and Welfare to improve regulations by gathering these voices from the field. As a result, a regulatory sandbox was implemented from April to October this year, granting special exceptions that allow for the submission of advanced regenerative medicine treatment plans even when commercial clinical trial results are already available. Baek Chang-wook, Secretary-General of CARM, stated, "We welcome the government's proactive review and look forward to seeing results." Regarding the regulatory sandbox, a Ministry of Health and Welfare official responded, "We are currently reviewing the submitted applications and proceeding with the selection of project operators."