Bill Expanding Access to Stem Cell Treatments for Intractable Diseases Passes National Assembly Plenary Session

Amendment to the Advanced Regenerative Bio Act Introduces Treatment Options for General Patients and Expands Eligibility for Clinical Research

On December 13, 2022, Minister of Health and Welfare Cho Kyoo-hong chairs a meeting of the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Policy Review Committee at the Press Center in Jung-gu, Seoul.
Yonhap News file photo

SEOUL, Feb. 1 (Yonhap) — Reporters Na Hwak-jin and Kwon Ji-hyun — A bill designed to expand access to advanced regenerative medicine, including stem cell-based treatments, for patients with intractable diseases has passed the National Assembly.

The Ministry of Health and Welfare announced on the 1st that eight bills under its jurisdiction, including an amendment to the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, had passed the National Assembly plenary session.

Under the revised law, cell and gene therapies may be provided to patients with serious, rare, or intractable diseases, and treatment costs may be charged. Until now, with only a few exceptional cases, such therapies were generally limited to pre-approved clinical research participants and could not be provided on a paid treatment basis.

The restrictions had prompted criticism that some patients were forced to travel overseas, including to Japan, to seek treatment.

The ministry said the amendment includes several safeguards. Treatment plans submitted by designated institutions will undergo prior review, and high-risk therapies may be required to undergo clinical research before they can be considered for treatment.

The amendment also eases licensing requirements related to the management of human cells. Previously, even medical institutions were required to obtain a human cell management business license in order to collect and test patients’ cells and supply them as raw materials for pharmaceutical products.

Under the revised law, however, medical institutions designated by the Minister of Health and Welfare to provide advanced regenerative medicine may supply patient-derived cells as raw materials for advanced biopharmaceuticals without a separate license, provided the cells undergo only minimal manipulation, such as simple isolation, washing, freezing, or thawing.

The Ministry of Food and Drug Safety said the amendment is expected to expand treatment opportunities for patients using advanced biopharmaceuticals, including gene therapies.

CHA Biotech, which develops cell therapies using stem cells, also welcomed the revision. The company said that once the amended law takes effect, even patients who are not enrolled in clinical trials may be able to receive cell therapies if they meet the relevant criteria. This could provide patients with malignant brain tumors and other conditions lacking alternative treatments an opportunity to receive investigational immune cell therapies currently under development by the company.

Other bills passed during the session included an amendment to the National Health Insurance Act, which expands the housing debt deduction available when calculating property-based health insurance premiums for self-employed subscribers. The amendment adds mortgage loans provided through the Housing and Urban Fund, including government-backed jeonse and home-purchase loan programs.

An amendment to the law on improving the training environment and status of medical residents also establishes a legal basis for providing priority support to specialties in need of better training conditions and for setting maximum limits on continuous working hours for residents.

Other measures passed include amendments to the Pharmaceutical Affairs Act, introducing penalties for obstructing pharmacists’ work or using violence in pharmacies, and the Organ Transplant Act, requiring information on organ donation to be provided when identification documents are issued.

The newly passed bills will take effect on the dates specified in each law after being promulgated by the President.

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Source: Yonhap News Agency