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Taiwan: Regulation of Stem Cell Preservation Businesses

(Apr. 29, 2009) According to the Director-General of the Bureau of Medical Affairs of Taiwan's Department of Health (DOH), Shih Chung-liang, in comments made on April 15, 2009, new stem cell storage companies – including new umbilical cord banks and preservation services for bone marrow, bone, skin, and teeth – must be approved by the DOH and be registered to receive a permit. Failure to do so will incur a fine, he stated. The only exemption from the registration requirement is for companies providing stem cell preservation services for the purpose of medical research. (Jimmy Chuang, DOH to Regulate Stem Cell Preservation Businesses, TAIPEI TIMES, Apr. 16, 2009, at 2, available at Permits are valid for three years.

Already existing companies must also complete registration, with a deadline of the end of August, or face a fine for violation of the Medical Care Act. “By law,” Shih stated, “the DOH regards businesses involved in the preservation of human tissue or organs as special businesses so they will need to complete registration.” (Id.) Companies storing stem cells from teeth (?) must submit a proposal for a human experiment from a major hospital in order to obtain DOH approval. “Stricter regulation of such companies is needed,” Shih was quoted as saying, because “there is insufficient evidence or experimental data to prove that [milk teeth stem-cell storage] is safe.” He added that the quality of stored stem cells, organs, and human tissue must be ensured in order to avoid potential medical disputes. (Id.)

Taiwan's Department of Health (DOH) also issued a statement on April 15, 2009, on the current administration and use of human organ storage banks in Taiwan. The statement notes first that, on February 2, 2009, the DOH had issued the Measures on the Administration of Human Organ Banks, in conformity with the authorizing provision (art. 14, para. 2) of the Human Organ Transplant Regulations (issued on June 19, 1987; last amended 2003). The Measures stipulate that those engaged in the handling or storage of human organs (including human tissue and cells) and their derivatives for the purpose of transplantation should apply to establish a human organ storage bank in conformity with the Measures (art. 2, para. 1). (Current Management Situation and Explanation of Use of Human Organ Preservation Banks [in Chinese], DOH website, Apr. 15, 2009, available at
; Statute for Human Organ Transplant, 4783 THE GAZETTE OF THE OFFICE OF THE PRESIDENT 1-2 (June 19, 1987), available at

The statement also indicates concern about storage banks advertising their services. For example, it points to the stipulation in the Measures that institutions must not publish storage bank advertisements whose content is exaggerated and untrue (art. 16). The statement adds that while biotechnology companies are not medical institutions whose medical advertising activities are restricted under the Medical Care Act [promulgated on Nov. 24, 1986; last amended on Jan. 7, 2009], the content of their advertisements is nevertheless subject to the same sanctions applicable to medical advertisements that contravene that Act (see arts. 84-87, 103-104). (Current Management Situation and Explanation of Use of Human Organ Preservation Banks, supra; Medical Care Act (as last amended), DOH website, (last visited Apr. 24, 2009); see also Amendment to Medical Treatment Law, 6841 THE GAZETTE OF THE OFFICE OF THE PRESIDENT (Jan. 7, 2009), available at”>214446.)