The Ministry of Health and Welfare will consider taking legal action against a Korean biotech company involved in illegal stem cell operations of Korean patients in Japan and China, officials said on Monday.
The move came after a Japanese newspaper reported on a dermatology clinic in Fukuoka administering stem cell injections to hundreds of Korean patients a month.
About 500 patients a month were injected with manufactured stem cells in hospitals without approval in Korea, by a Seoul-based bio venture RNL Bio Co., according to the report by Mainichi Shinmun. About 3,700 Korean patients received the treatments in hospitals in Japan since 2009 and about 11,500 in China, it quoted RNL officials as saying.
The stem cell company connected patients to foreign partner clinics for injections because the procedures are banned under a Korean drug law, but not in Japan.
Due to the safety issue, which has not yet been proven globally, the laboratory formulation is only allowed when it is conducted for research purposes along with approval from the drug agency. Violators are subjected to up to five years in jail or a fine of up to 20 million won.
"We have to look into facts, but it is clearly a violation of Korean drug law if (the company) cultured stem cells without approval in Korea and injected them into patients," an official at the ministry said.
"But if the stem cells were manufactured and injected overseas, it would be hard to apply a local law to the case," he added.