In South Korea, stem cells used for therapeutic purposes should be regarded as medicine, according to the recent Supreme Court ruling. Therefore, stem cell treatment has to get approval from Food and Drug Administration before being administered on patients.
According to the Korean Supreme Court, the hospitals providing stem cell treatment should compensate patients the damages caused by stem cell transplantations. This decision supported the earlier lower court's ruling in a suit of nine patients against a Seoul clinic they received treatment at. The plaintiffs claimed that the treatment they received proved to be not as effective as was promised, and one of the patients even died soon after the treatment.
The court's ruling states that stem cells are considered a medicine if they are used for treatment purposes. That means that clinics practicing stem cell transplantation should get approval from the drug administration.
The court ruled in favour of plaintiffs as the clinic they had treatment at failed to fully inform the patients about the limitations and risks of the treatment. The clinic was ordered to pay 16 to 30 million won to each of the plaintiffs, who paid 20 to 30 million won for the treatments.
Although the plaintiffs demanded 40 to 50 million won in compensation, the court restricted the clinic's liability because the patients were partially informed about treatment effects and risks but insisted on it anyway.