New stem cell storage businesses, including umbilical cord blood banks, will have to be approved by the Department of Health (DOH), health authorities said yesterday, adding that those who fail to do so would be fined.
Shih Chung-liang (石崇良), the director-general of the Bureau of Medical Affairs, said that new operators of umbilical cord blood banks, as well as bone marrow, bone, skin and teeth preservation services, are required to register their business.
Only companies that provide stem cell preservation services for medical research purposes are exempted.
Companies that are already in existence must also complete their registration before the end of August or they will be fined for violating the Medical Care Act (醫療法). The DOH did not give any details on how much the fine will be.
“By law, the DOH regards businesses involved in the preservation of human tissue or organs as special businesses so they will need to complete registration,” Shih said.
For the storage of teeth stem cells, Shih said applicants will be required to submit a human experiment proposal from a major hospital to obtain the DOH's approval.
Shih said two companies recently began offering milk teeth stem cell preservation services. Stricter regulation of such companies is needed as there is insufficient evidence or experimental data to prove that it is safe, he said.
“We need to ensure the quality of these preserved stem cells, organs or human tissues, so potential medical arguments can be avoided,” Shih said.